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Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial

This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Cecilia Ethun
213723
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05863195
STU-2024-0075
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Inclusion Criteria:

• Patient must be >= 18 years of age
• Patient must have confirmed unresectable liver confined metastatic colorectal cancer (CRC).
• Patient must not have radiographically or clinically evident extrahepatic disease (including but not limited to radiographically positive periportal lymph nodes).
• NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study.
• Patient may have calcified pulmonary nodules, and/or =< 5 indeterminate and stable (for a minimum of 3 months on chemotherapy) pulmonary nodules each measuring =< 6 mm in maximal axial dimension.
• Patient's primary tumor may be in place.
• Patient must have received 3-6 months of previous first-line chemotherapy that meet one of the following three criteria: a) have received at least 6 but no more than 12 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 14 days) OR b) have received at least 4 but no more than 8 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 21 days) OR c) have developed new colorectal liver metastases (CRLM) within 12 months of completing adjuvant systemic therapy for stage II-III colorectal cancer.
• NOTE: First-line chemotherapy may have included any of the following regimens as listed in the National Comprehensive Cancer Network (NCCN) Guidelines: leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX) (or equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil, and irinotecan (FOLFIRI) (or equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil, oxaliplatin, and irinotecan (FOLFOXIRI), each with or without any of the following: bevacizumab, cetuximab, or panitumumab.
• Patient must have stable or responding disease on first-line chemotherapy by RECIST
• 1 criteria
• Patient must meet the following criteria for technical unresectability:
• A margin-negative resection requires resection of three hepatic veins, both portal veins, or the retrohepatic vena cava OR a resection that leaves less than two adequately perfused and drained segments.
• NOTE: Institutional multidisciplinary review is required to confirm unresectability and rule out radiographically positive extrahepatic disease.
• Patient must undergo CT angiography (chest/abdomen/pelvis) to confirm acceptable hepatic arterial anatomy for HAI and to rule out extrahepatic disease within 4 weeks prior to randomization.
• Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 and be clinically fit to undergo surgery as determined by the pre-operative evaluation.
• Leukocytes >= 3,000/mcL (obtained =< 14 days prior to protocol randomization)
• Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 14 days prior to protocol randomization)
• Platelets >= 100,000/mcL (obtained =< 14 days prior to protocol randomization)
• Total Bilirubin =< 1.5 mg/dL (obtained =< 14 days prior to protocol randomization)
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =<
• 0 x institutional upper limit of normal (ULN) (obtained =< 14 days prior to protocol randomization)
• Creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault method (obtained =< 14 days prior to protocol randomization)
• Calcium >= institutional lower limit of normal (LLN)
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for entry onto the study
Exclusion Criteria:

• Patient must not have a liver tumor burden exceeding 70% of total liver volume.
• Patient must not have had prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 2 weeks prior to randomization).
• Patient must not have had prior trans-arterial bland embolization, chemoembolization (TACE) or radioembolization (TARE).
• Patient must not have had prior treatment with HAI/floxuridine (FUDR)
• Patient must not have microsatellite instability-high (MSI-H) colorectal cancer.
• Patient must not have CRLM that could be resected with 2-stage hepatectomy, including associating liver partition and portal vein ligation (ALPPS).
• Patient must not have an active infection, serious or non-healing active wound, ulcer, or bone fracture.
• Patient must not have any serious medical problems which would preclude receiving the protocol treatment or would interfere with the cooperation with the requirements of this trial.
• Patient must not have cirrhosis and/or clinical or radiographic evidence of portal hypertension
• Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
• All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.
• A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
• Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study.
Biological: Bevacizumab, Biological: Cetuximab, Procedure: Computed Tomography, Drug: Floxuridine, Drug: Fluorouracil, Procedure: Implantation, Procedure: Intrahepatic Infusion Procedure, Drug: Irinotecan, Drug: Leucovorin, Drug: Oxaliplatin, Biological: Panitumumab, Procedure: Single Photon Emission Computed Tomography
Colon, Liver, Rectum, Metastatic Malignant Neoplasm in the Liver, Stage IV Colorectal Cancer AJCC v8, Unresectable Colorectal Carcinoma, Metastatic Colorectal Carcinoma
UT Southwestern
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Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies

Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with oligoprogressive solid tumor malignancies after prior anti-cancer therapy.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Mona Arbab
212798
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05846659
STU-2023-0837
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Inclusion Criteria:

• Male or female patients ≥ 18 years of age
• Signed informed consent and mental capability to understand the informed consent
• Histologically or cytologically documented solid tumor malignancies demonstrating new progression through prior anti-cancer therapy, with a prior 2 months of clinical stability (with at least Stable Disease), with radiographically documented presence of ≤ 6 metastatic lesions consistent with the diagnosis of "oligoprogressive" disease that are technically amenable to PULSAR
• Patient's disease must be evaluable per RECIST Version 1.1
• All metastatic lesions amenable to administration of radiotherapy, at the discretion of the investigator
• Must have at least one single pre-defined progressing lesion/lesion site (longest diameter ≥ 10 mm and ≤ 50 mm) suitable for intra-tumoral injection
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• Electrocardiogram (ECG) without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the investigator
• Acceptable organ and marrow function as defined below:
• Absolute neutrophil count (ANC) > 1,500 cells/μL
• Platelets > 50,000 cells/μL
• Total bilirubin ≤ 1.5 times (×) the upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransaminase (ALT) ≤ 2.5 × ULN. If liver metastases are present, AST/ALT < 5 × ULN
• Serum creatinine < 1.5 mg/dL and a measured creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula
• Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 × ULN
• Women of child-bearing potential (defined as a female who has experienced menarche and who has not undergone successful surgical sterilization [hysterectomy, bilateral salpingectomy, or bilateral oophorectomy]) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months with an appropriate clinical profile at the appropriate age, eg, greater than 45 years) must have a negative serum pregnancy test prior to first dose of study treatment
• Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study
Exclusion Criteria:

• Prior receipt of stimulator of interferon genes (STING) agonist
• Prior receipt of therapeutic radiotherapy to all progressive lesions intended for PULSAR treatment
• Anti-cancer therapy, except pembrolizumab and nivolumab, within 4 weeks or < 5 half-lives of the first dose of study treatment
• Existence of primary tumor that requires therapeutic treatment beyond the provided immune checkpoint inhibitor drug
• Failure to recover, to Grade 1 or less, from clinically significant AEs due to prior anti-cancer therapy, as judged by the investigator
• Previous life-threatening (Grade 4) immune-related adverse event (irAE)
• Known untreated brain metastases or treated brain metastases that have not been stable (scan showing no worsening of central nervous system [CNS] lesion[s] and no requirement of corticosteroids) ≥ 4 weeks prior to study enrollment
• Existence of actionable mutations that are eligible for a mutation-targeting drug that represents standard-of-care
• Baseline prolongation of QT/corrected QT (QTc) interval (QTc interval > 470)
• Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations) that in the opinion of the investigator would limit compliance with study requirements
• Women who are pregnant or breastfeeding
• Sponsor reserves the right to exclude any patient from the study on the basis of pre-study medical histories, physical examination findings, clinical laboratory results, prior medications, or other entrance criteria
Drug: IMSA101, Drug: Immune checkpoint inhibitor, Radiation: PULSAR
Other, Eye and Orbit, Anus, Breast - Female, Breast - Male, Cervix, Colon, Corpus Uteri, Esophagus, Gall Bladder, Head and Neck, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung/Thoracic, Melanoma, skin, Ovary, Pancreas, Prostate, Rectum, Stomach, Throat, Thyroid, Urinary Bladder, Uterine (Endometrial), Vulva, Small Intestine, Unknown Sites, Oligoprogressive
Oligoprogressive solid tumor malignancies, Adult
UT Southwestern
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The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation (REACT-AF)

REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Vukile.Mlambo@utsouthwestern.edu

Mark Link
171002
All
22 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05836987
STU-2023-0473
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Inclusion Criteria:

• Male or female, 22-85 years of age.
• English speaking participants*
• Documented history of symptomatic or asymptomatic paroxysmal or persistent AF. The duration of AF must have been > 30 seconds as documented by an external monitor or present on 12-lead ECG.
• CHA2DS2-VASC score of 1-4 without prior stroke or Transient Ischemic Attack (TIA)**
• The participant is on a DOAC at the time of screening.
• Willing and able to comply with the protocol, including:
• Possession of a smartwatch-compatible smartphone (iPhone that supports the latest shipping iOS) with a cellular service plan
• Be willing to wear the Apple watch at least 14 hours a day
• Expected to be within cellular service range at least 80% of the time
• Willing and able to discontinue DOAC
• The participant is willing and able to provide informed consent.
Exclusion Criteria:

• Valvular or permanent atrial fibrillation.
• Current treatment with warfarin and unwilling or unable to take a DOAC.
• The participant is a woman who is pregnant, nursing, or of child-bearing potential and is not on birth control.
• The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration.
• Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor.
• Any documented single AF episode lasting ≥ 1 hour on screening external cardiac monitor of >=6 days duration.
• Mechanical prosthetic valve(s) or severe valve disease.
• Hypertrophic cardiomyopathy.
• Participant needs Direct Oral Anticoagulation (DOAC) for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)) or needs permanent Oral Anticoagulant (OAC) (i.e., congenital heart defects, prosthetic heart valve).
• Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis > 75%) based on the investigator's discretion.
• The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial.
• The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.
• The participant has a tremor on their ipsilateral side that the AFSW may be worn.
• Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
• Known hypersensitivity or contraindication to direct oral anticoagulants.
• Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.
• Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.
• > 5% burden premature atrial or ventricular depolarizations on any given calendar day on pre-enrollment cardiac monitoring.
• History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment).
• Stage 4 or 5 chronic kidney disease.
• Conditions associated with an increased risk of bleeding:
• Major surgery in the previous month
• Planned surgery or intervention in the next three months.
• History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra-articular bleeding
• Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery)
• Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
• Hemorrhagic disorder or bleeding diathesis
• Need for anticoagulant treatment for disorders other than AF
• Required use of non-aspirin antiplatelet agents (i.e., Plavix) at time of enrollment
• Uncontrolled hypertension (Systolic Blood Pressure (SBP) >180 mmHg and/or Diastolic Blood Pressure( DBP) >100 mmHg)
• Spanish-only speakers may be included in the future at select sites where consent forms are appropriately translated.
• Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and/or ejection fraction < 40%
Device: AFSW Guided DOAC, Drug: Continuous DOAC therapy
Atrial Fibrillation
Atrial Fibrillation, Anticoagulation, AF-sensing Smart Watch, Ischemic Stroke, Systemic Embolism
UT Southwestern
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Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer

This phase II trial tests how well M1774 works in treating patients with prostate cancer that does not respond to treatment (refractory) and that has a mutation in the gene responsible for making the speckle type BTB/POZ protein (SPOP). M1774 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving M1774 may be able to shrink or stabilize refractory SPOP-mutant prostate cancer.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Kevin Courtney
131906
Male
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05828082
STU-2024-0158
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Inclusion Criteria:

• Presence of SPOP mutations in prostate cancer cells, as indicated by Next Generation Sequencing (NGS)
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with CT scan, MRI, or calipers by clinical exam
• Castrate-range testosterone (< 50 ng/dL) after androgen deprivation therapy (ADT) or orchiectomy
• Prior treatment with second generation anti-androgen (2GAA) and taxane- or lutetium-based therapy
• Age >= 18 years. Because no dosing or adverse event data are currently available on the use of M1774 in patients < 18 years of age, children are excluded from this study
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase [SGPT]) =< 3 x institutional ULN
• Creatinine =< 1.5 × ULN
• Creatinine clearance >= 60 mL/min
• Creatinine clearance should be measured if estimated glomerular filtration rate (eGFR) is > 60 mL/min
• Hemoglobin >= 9.0g/dL
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
• Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
• The effects of M1774 on the developing human fetus are unknown. For this reason and because ATR inhibitors may be teratogenic (Musson et al., 2022), women of child-bearing potential who are partners of men enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to the study, for the duration of study participation, and 6 months after completion of M1774 administration. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately. Men enrolled on this study must agree to use adequate contraception prior to study entry, for the duration of study participation, and 3 months after completion of M1774 administration
• Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Exclusion Criteria:

• Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
• Patients who are receiving any other investigational agents
• Patients with uncontrolled intercurrent illness
• Patients who cannot discontinue proton pump inhibitors (PPIs). H2 receptor antagonists will not be permitted within 12 hours before dosing of M1774 and until 2 hours after dosing of M1774. Antacids will not be permitted within 2 hours before and 2 hours after administration of M1774
• Patients who cannot discontinue drugs that are strong inhibitors of CYP3A4 or CYP1A2
• Patients who cannot discontinue drugs that are hMATE1 or hMATE2-Ksubstrates
• Patients with a baseline QC interval > 470 msec
Procedure: Biopsy, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Drug: Tuvusertib, Procedure: Ultrasound Imaging
Refractory Prostate Carcinoma
UT Southwestern
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A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis

This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Erin Butler
104034
All
180 Days to 22 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT05828069
STU-2023-0818
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Inclusion Criteria:

• 180 days- < 22 years (at time of study enrollment)
• Patients with multifocal progressive, relapsed, or recurrent LCH with measurable disease at study entry
• Patients must have had histologic verification of LCH (from either original diagnosis or relapse/progression) at the time of study entry (must be obtained within 28 days prior to enrollment and start of protocol therapy) (repeat if necessary)
• Tissue confirmation of relapse is recommended but not required
• Pathology report must be submitted for central confirmation of diagnosis within 7 days of enrollment.
• Formalin-fixed paraffin-embedded (FFPE) blocks or unstained slides (initial diagnosis and/or subsequent biopsies) will be required for retrospective central confirmation of diagnosis and molecular studies
• Patients with mixed histiocytic disorders (e.g. LCH with juvenile xanthogranuloma) may be included
• Patients must have measurable disease, documented by radiographic imaging (LCH- specific response criteria (must be obtained within 28 days prior to enrollment and start of protocol therapy) (repeat if necessary).
• Patients must have progressive or refractory disease or experience relapse after at least one previous systemic chemotherapy treatment strategy
• Pathogenic somatic mutation detected in genes encoding tyrosine kinase receptors (CSFR1, ERBB3 or ALK), RAS or RAF (may be from original or subsequent biopsy or peripheral blood/bone marrow aspirate). Clinical mutation reports may include quantitative polymerase chain reaction (PCR) (e.g. BRAFV600E) and/or Sanger or next generation sequencing. Immunohistochemistry (e.g. VE1 antibody for BRAFV600E) alone is not sufficient
• Participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet, which may be taken by mouth or other enteral route such as nasogastric, jejunostomy, or gastric tube
• Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50% for patients =< 16 years of age
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
• Myelosuppressive chemotherapy: Patients must not have received within 14 days of entry onto this study
• Investigational agent or any other anticancer therapy not defined above: Patients must not have received any investigational agent for at least 14 days prior to planned start of tovorafenib (DAY101)
• Radiation therapy (RT): Patient must not have received RT within 2 weeks after the last dose fraction of RT
• Patients must have fully recovered from any prior surgery
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy with toxicities reduced to Grade 1 or less (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0)
• Steroids: < 0.5 mg/kg/day of prednisone equivalent (maximum 20 mg/day) averaged during the month prior to study enrollment is permissible but must be discontinued fourteen (14) days prior to study enrollment. Patients with documented brain lesions receiving corticosteroids for management of cerebral edema must be on a stable dose for fourteen (14) days prior to study enrollment
• Strong inducers or inhibitors of CYP2C8 are prohibited for 14 days before the first dose of tovorafenib (DAY101) and from planned administration for the duration of study participation
• Medications that are breast cancer resistant protein (BCRP) substrates that have a narrow therapeutic index are prohibited for 14 days before the first dose of tovorafenib (DAY101) and for the duration of study participation
• Peripheral absolute neutrophil count (ANC) >= 750/uL unless secondary to bone marrow involvement, in such cases bone marrow involvement must be documented (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if > 7 days have elapsed from their most recent prior assessment)
• Platelet count >= 75,000/uL (unsupported/without transfusion within the past 7 days) (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if > 7 days have elapsed from their most recent prior assessment)
• Patients with marrow disease must have platelet count of >= 75,000/uL (transfusion support allowed) and must not be refractory to platelet transfusions. Bone marrow involvement must be documented
• Hemoglobin >= 8 g/dL (unsupported/without transfusion within the past 7 days). Patients with marrow disease must have hemoglobin >= 8 g/dL (transfusion support allowed). Bone marrow involvement must be documented
• Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g., Neulasta [registered trademark]) or 7 days for short-acting growth factor
• A serum creatinine based on age/gender as follows (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if > 7 days have elapsed from their most recent prior assessment)
• Age: 6 months to < 1 year; Maximum Serum Creatinine (mg/dL):= 0.5 mg/dl (male and female)
• Age: 1 to < 2 years; Maximum Serum Creatinine (mg/dL): = 0.6 mg/dl (male and female)
• Age: 2 to < 6 years; Maximum Serum Creatinine (mg/dL): = 0.8 mg/dl (male and female)
• Age: 6 to < 10 years; Maximum Serum Creatinine (mg/dL): = 1.0 mg/dl (male and female)
• Age: 10 to < 13 years; Maximum Serum Creatinine (mg/dL): = 1.2 mg/dl (male and female)
• 13 to < 16 years; Maximum Serum Creatinine (mg/dL): = 1.5 mg/dl (male) and 1.4 mg/dl (female)
• Age: >= 16 years; Maximum Serum Creatinine (mg/dL): = 1.7 mg/dl (male) and 1.4 mg/dl (female)
• OR- a 24 hour urine creatinine clearance >= 50 mL/min/1.73 m^2
• OR- a glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
• Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
• Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if > 7 days have elapsed from their most recent prior assessment)
• Alanine aminotransferase (ALT) =< 3 x ULN for age (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if > 7 days have elapsed from their most recent prior assessment)
• Serum albumin >= 2 g/dl must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if > 7 days have elapsed from their most recent prior assessment)
• For patients with liver disease caused by their histiocytic disorder (as evaluated on radiographic imaging or biopsy): patients may be enrolled with abnormal bilirubin, aspartate aminotransferase (AST), ALT and albumin with documentation of histiocytic liver disease
• Fractional shortening (FS) of >= 25% or ejection fraction of >= 50%, as determined by echocardiography or multigated acquisition scan (MUGA) within 28 days prior to study enrollment. Depending on institutional standard, either FS or left ventricular ejection fraction (LVEF) is adequate for enrollment if only one value is measured; if both values are measured, then both values must meet criteria above (must be obtained within 28 days prior to enrollment and start of protocol therapy) (repeat if necessary)
• No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination; unless it is due to underlying pulmonary LCH
• Central Nervous System Function Defined As:
• Patients with seizure disorder may be enrolled if well controlled
• Central nervous system (CNS) toxicity =< Grade 2
• Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial unless antiretroviral therapy interacts with the metabolism of tovorafenib (DAY101) and cannot safely be changed to antivirals that do not interact with study medication
Exclusion Criteria:

• LCH arising along with other hematologic malignancy (e.g. mixed LCH with acute lymphoblastic leukemia) or any history of non-histiocytic malignancy
• Disease scenarios as below will be excluded
• Skin-limited disease
• Single bone lesion
• Gastrointestinal (GI) tract involvement only (those that have disease that can be determined by endoscopic biopsies only)
• LCH-associated neurodegeneration (LCH-ND) without parenchymal lesions or other systemic lesions
• Patients with activating mutations in MAP2K1 are not eligible for this study due to drug target specificity. Mutation status will be submitted to study team within 7 days of enrollment
• Patient must not have received any prior MAPK pathway inhibitor therapy
• Refractory nausea and vomiting, malabsorption, or external biliary shunt that would preclude adequate absorption of tovorafenib (DAY101)
• Uncontrolled systemic bacterial, viral, or fungal infection
• Major surgical procedure or significant traumatic injury within 14 days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study. Placement of a vascular access device or minor surgery is permitted within fourteen (14) days of study enrollment (provided that the wound has healed)
• History of significant bowel resection that would preclude adequate absorption or other significant malabsorptive disease
• Ophthalmologic considerations: Patients with known significant ophthalmologic conditions or known risk factors for retinal vein occlusion (RVO) or central serous retinopathy (CSR) are not eligible
• History of solid organ or hematopoietic bone marrow transplantation
• Clinically significant active cardiovascular disease, or history of myocardial infarction, or deep vein thrombosis/pulmonary embolism within 6 months prior to enrollment, ongoing cardiomyopathy, or current prolonged QT interval > 440 ms based on triplicate electrocardiogram (ECG) average
• History of Grade >= 2 CNS hemorrhage or history of any CNS hemorrhage within 28 days of study entry
• History of any drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome or Stevens Johnsons syndrome (SJS) or who are allergic to tovorafenib (DAY101) or any of its components
• CTCAE version (V). 5.0 Grade 3 symptomatic creatinine kinase (CPK) elevation ( > 5 x ULN)
• Female patients who are pregnant are ineligible. A pregnancy test is required for female patients of childbearing potential
• Lactating females who plan to breastfeed their infants are ineligible
• Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation are ineligible. Participants (male and female) who are sexually active must use two forms of an acceptable method of birth control (for men, one form must be a barrier method) from start of therapy through 180 days following last dose of tovorafenib (DAY101)
Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Procedure: Computed Tomography, Procedure: Echocardiography, Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan, Procedure: Lumbar Puncture, Procedure: Multigated Acquisition Scan, Drug: Tovorafenib
Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
Children’s Health
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A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Daphne.Fuerte@UTSouthwestern.edu

Venkateswara Mootha
35544
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05826353
STU-2023-0333
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Inclusion Criteria:

• Is at least 18 years old at the screening visit (Visit 1)
• Has a diagnosis of FECD at Visit 1
• Meet all other inclusion criteria outlined in the Clinical Study Protocol.
Exclusion Criteria:

• Is a female subject of childbearing potential and any of the following is true:
• is pregnant or lactating/breastfeeding, or
• is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy)
• Meet any other exclusion criteria outlined in the Clinical Study Protocol.
Drug: Ripasudil, Drug: Placebo
Eye and Orbit, Fuchs Endothelial Corneal Dystrophy
UT Southwestern
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Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial

COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Olakunbi.Latona@UTSouthwestern.edu

Mamta Jain
41138
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT05822583
STU-2023-0123
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Inclusion Criteria:

• Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non-NAT test [list of approved tests in the PIM] within 14 days of randomization.
• Requiring hospitalization for the management of COVID-19
• Has evidence of COVID-19 pneumonia (PNA) defined as either receiving supplementary oxygen ≤2L of low flow oxygen with evidence of airspace disease on chest imaging (X ray, computer tomography or ultrasound) OR receiving supplementary oxygen >2L and <10 L of low flow oxygen.
• Currently receiving or planned to receive (ordered) one IM drug (for example, a corticosteroid or baricitinib) as part of treatment of COVID-19 prior to randomization.
• Has started supplemental oxygen for the treatment of COVID-19 within the past 5 calendar days. Patients on home oxygen are eligible if current oxygen flow rate is increased from baseline and other above criteria are met.
• Investigator agrees that the pneumonia is due to COVID-19.
Exclusion Criteria:

• Oxygen requirement of ≥10L or more of low flow oxygen (or equivalent if using Venturi mask, etc), or requiring either HFNO, NIV, IMV, or ECMO.
• Participant has received more than one baseline IM for treatment of the current COVID-19 infection at time of trial enrollment. (Examples: corticosteroid, baricitinib, tocilizumab, anakinra, abatacept, or infliximab.)
• Participant anticipated to not meet all inclusion criteria within 24 hours of randomization in the opinion of the investigator.
• Allergy to investigational agent.
• Neutropenia (absolute neutrophil count <1000 cells/μL) (<1.0 x 10 3 /μL or <1.0 G/L) on most recent lab within 2 calendar days of randomization.
• Lymphopenia (absolute lymphocyte count <200 cells/μL) (<0.20 x 10 3 /μL or <0.20 G/L) on most recent lab within 2 calendar days of randomization.
• Known or suspected active or recent serious infection (bacterial, fungal, viral, or parasitic infection, excepting SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking investigational agent. Note: Broad spectrum empiric antibiotic usage does not exclude participation.
• Known or suspected history of untreated tuberculosis (TB). TB diagnosis may be suspected based on medical history and concomitant therapies that would suggest TB infection. Participants are also excluded if they have known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
• Have received any live vaccine (or live attenuated) within 3 months before screening or intend to receive a live vaccine (or live attenuated) during the trial. Use of prior non-live (inactivated) vaccinations is allowed for all participants, including any vaccine for COVID-19.
• Pre-existing immunomodulation or immunosuppression that meets any of the following: Participant has received abatacept for an indication other than COVID- 19 within 5 half-lives (65 days) of enrollment (Abatacept elimination half-life is 13.1 days.) Participant is receiving immune modulatory therapy for autoimmune, transplant management or another indication AND has one or more of the following: evidence of active infection (other than COVID-19) or has required reduction in their immune modulatory therapy in the preceding 6 months due to infectious complication (routine reduction as SOC is not an exclusion) or has required intensification in immunotherapy within the preceding 6 months due to organ rejection/worsening underlying disease status (e.g., intensification with an additional agent on top of usual immunosuppressive regimen)
• Participant has recently received or is anticipated to require immune modulatory agents for their underlying disease including chemotherapeutic treatments likely to induce neutropenia (<1.0 x 10 9 cells/µL) or lymphopenia (<1.0 x 10 9 cells/µL)
• Participant has untreated advanced HIV (known CD4 <200 in the past 6 months) AND is not established on antiretroviral therapy
• Pregnancy
• Breastfeeding
• Co-enrollment in other trials not predetermined to be compatible with this trial.
• In the investigator's judgment, the patient has any advanced organ dysfunction that would not make participation appropriate.
• The treating clinician expects inability to participate in trial procedures or participation would not be in the best interests of the patient.
Drug: abatacept infusion, Drug: Placebo group
COVID-19
UT Southwestern; Parkland Health & Hospital System
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Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia

Type I hyperlipoproteinemia (T1HLP, also known as familial chylomicronemia syndrome or FCS) is a rare diseasewhere the blood triglycerides (fats) are very high. It is caused by lack of certain enzymes and proteins in the bodythat are important in disposing circulating fats from blood. Treatment of T1HLP patients who have very high levels of blood fats (≥ 1,000 mg/dL) is challenging as conventional triglyceride-lowering medications, such as fibrates and fishoil, are ineffective. The purpose of this trial is to study the long-term efficacy and safety of orlistat for reducing blood triglyceride levels in patients with T1HLP.

Call 214-648-5005
studyfinder@utsouthwestern.edu, CHANDNA.VASANDANI@UTSouthwestern.edu

Abhimanyu Garg
12461
All
8 Years to 70 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT05816343
STU-2019-0776
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Inclusion Criteria:

• Type I hyperlipoproteinemia confirmed by bi-allelic disease-causing variants in any one of the T1HLP genes (LPL, APOC2, APOA5, LMF1, GPIHBP1, or GCKR).
• Fasting serum triglyceride levels of greater than 750 mg/dL.
• Age 8-70 years
• Effective contraception for males and females of childbearing age.
• Off orlistat for a period of 2 months.
Exclusion Criteria:

• Secondary hypertriglyceridemias due to diabetes, renal disease, hypothyroidism, alcoholism and drug therapy such as estrogens and estrogen analogues, steroids, HIV-1 protease inhibitors, retinoic acid derivatives, interferons, or l-asparaginase.
• On lomitapide or participating in clinical trial of volanesorsen
• Pregnant or lactating women
• Significant liver disease (elevated transaminases > 2 times upper limit of normal)
• Alcohol abuse (> 7 drinks or 84 g per week for women and > 14 drinks or 168 g per week for men)
• Severe anemia (hematocrit < 24%)
• Illicit drug use (cocaine, marijuana, LSD, etc.)
• Major surgery in the past three months
• Congestive heart failure
• Serum creatinine greater than 2.5 mg/dL
• Cancer within the past five years
• Gastrointestinal surgery in the past
• Current therapy with anti-coagulants, digoxin and anti-arrhythmics
• Chronic malabsorption syndromes
• Cholestasis
• Acute illnesses such as acute pancreatitis in the last 8 weeks
• Previous history of renal calcium oxalate stones
Drug: Orlistat, Drug: Placebo
Type 1 Hyperlipoprotenemia
UT Southwestern
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Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Heather McArthur
195731
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05812807
STU-2023-0742
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Inclusion Criteria:

• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Triple Negative Breast Cancer:
• Patients with a history of stage T1cN1-2 or T2-4N0-2 breast cancer according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator in radiologic assessment, clinical assessment or both
• Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Isolated tumor cells are considered node-negative
• Estrogen (ER) and progesterone (PR) =< 10%; HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (immunohistochemistry [IHC] and fluorescence in situ hybridization [FISH])
• If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts
• Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy and ICI therapy should have been completed preoperatively
• An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization * Note: Adjuvant radiation can be given on study. If given, it is encouraged to be given concurrently with pembrolizumab, per investigator discretion. Treatment with adjuvant pembrolizumab is strongly discouraged prior to participation in this trial, but if administered (e.g., if patients are awaiting pathology results), pembrolizumab may be administered for up to 6 weeks post-surgery and must be completed prior to registration
• Use of investigational anti-cancer agents must be discontinued at time of registration
• Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
• Breast surgery: Total mastectomy or breast-conserving surgery with histologically negative margins, including no ink on tumor for DCIS, at the time of excision ** For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of ductal carcinoma in-situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates DCIS at the line of resection, additional operative procedures may be performed to obtain clear margins. If DCIS is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection
• Lymph node surgery:
• For a patient with clinically N0 disease, a sentinel lymph node biopsy should have been performed at time of surgical evaluation, and if pathologically node positive, the patient is no longer eligible. Isolated tumor cells are considered node-negative
• For a patient with clinically N1 disease at diagnosis (with positive results from a fine-needle aspiration, core biopsy, or sentinel node biopsy performed prior to preoperative therapy) additional surgical evaluation of the axilla following preoperative therapy is required *** If they become cN0 (no palpable adenopathy), then a sentinel lymph node biopsy could have been performed at time of surgery (axillary dissection would also be permitted); if the sentinel lymph node biopsy is positive, the patient is no longer eligible
• If sentinel node biopsy performed before preoperative therapy was negative, no additional surgical evaluation of the axilla is required after preoperative therapy. If sentinel node biopsy performed before preoperative therapy was positive, an ALND is required after preoperative therapy
• If the only sentinel node identified by isotope scan is in the internal mammary chain, surgical evaluation of the axilla is still required
• If sentinel node evaluation after preoperative therapy is negative, no further additional surgical evaluation of the axilla is required
• Axillary dissection without sentinel node evaluation is permitted as the initial or sole axillary evaluation after preoperative therapy
• If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible
• Not pregnant and not nursing, because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 7 days prior to randomization is required
• Absolute neutrophil count (ANC) >= 1,000/mm^3
• Platelet Count >= 100,000/mm^3
• Estimated glomerular filtration rate (eGFR) >= 15 mL/min/1.73m^2
• Total Bilirubin =<1.5 x upper limit of normal (ULN) * Patients with Gilbert's disease with a total bilirubin =< 2.5 x ULN and direct bilirubin within normal limits are permitted
• Aspartate aminotransferase (AST) serum aspartate aminotransferase [SGOT] / alanine aminotransferase (ALT) serum glutamic pyruvic transaminase [SGPT] =< 3 x institutional ULN
• Patients must be willing to provide tumor tissue from the diagnostic core biopsy. If inadequate tumor tissue is available, patients are still eligible to participate in the trial
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
Exclusion Criteria:

• No stage IV (metastatic) breast cancer
• No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed
• No evidence of recurrent disease following preoperative therapy and surgery
• No known active liver disease, e.g. due to hepatitis B virus (HBV), hepatitis C virus (HCV), autoimmune hepatic disorders, or sclerosing cholangitis
• No history of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any components of the product * Note: Prior immune-related adverse events (irAEs) are allowed if they resolved and the patient tolerated subsequent therapy without requiring chronic steroids for the irAE
• No medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy
• Patients who are unable or unwilling to comply with the requirements of the protocol per investigator assessment are not eligible
Biological: Pembrolizumab, Other: Patient Observation, Procedure: Biopsy, Procedure: Biospecimen Collection, Other: Questionnaire Administration, Other: Quality-of-Life Assessment
Anatomic Stage II Breast Cancer AJCC v8, Breast - Female, Breast - Male, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma
UT Southwestern; Parkland Health & Hospital System
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A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace) (PALace)

This is a 10-year multi-center, global, observational study to further characterize the safety profile of pegvaliase, including hypersensitivity reactions, long-term safety and tolerability, and the effectiveness of the additional risk minimization measures (aRMMs) (European Union (EU) only) in subjects receiving pegvaliase for the treatment of PKU. Subjects for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment (incident-users) or have previously started treatment with pegvaliase at the date of enrollment (prevalent-users) are eligible for participation in this study.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Juana.Luevano@UTSouthwestern.edu

Markey McNutt
59152
All
Not specified
This study is NOT accepting healthy volunteers
NCT05813678
STU-2023-0263
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Inclusion Criteria:

• Documented diagnosis of PKU per local standard of care
• Currently receiving or planned to receive pegvaliase treatment within 30 days after the date of enrollment, including subjects who previously received pegvaliase as part of the clinical development program and have completed study participation.
• Subject (or legally authorized representative) is willing and able to provide written informed consent after the nature of the study has been explained and prior to any data collection.
Exclusion Criteria:

• Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with any aspect of the study.
• Currently participating in an interventional study of any investigational product, device, or procedure
• Previously enrolled in this study (eg, subjects who have been withdrawn from the study and wish to participate again at a later date)
• German subjects <16 years if age
Drug: Pegvaliase
Phenylketonuria (PKU)
Observational, Safety Study, Pegvaliase, Palynziq, PKU, Phenylketonuria, Phase 4
UT Southwestern; Children’s Health
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The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Antonio.SolanoAvendano@UTSouthwestern.edu

Melissa Kirkwood
124886
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05811364
STU-2023-0754
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Inclusion Criteria:

• Age ≥ 18 years at time of informed consent signature
• Informed Consent Form (ICF) is signed by the subject
• Subject can comply with protocol requirements, including follow-up
• Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)
• Patient has de novo or restenotic lesion(s) found in the common and/or external iliac artery(ies)
• Patient has: Unilateral or bilateral single or multiple lesions (>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length
• Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm
• Patient has a sufficient (<50% stenotic) common femoral artery and at least one sufficient (<50% stenotic) femoral artery (deep or superficial).
• Patient has at least one sufficient (<50% stenotic) infrapopliteal run-off vessel.
Exclusion Criteria:

• Life expectancy <1 year
• Patient is pregnant at time of informed consent.
• Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).
• Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not undergoing hemodialysis.
• Patient has evidence of a systemic infection.
• Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.
• Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).
• Patient has previous stenting in the iliac arteries.
• Patient has previous surgical bypass in the target limb.
• Patient is currently participating in another investigative clinical study unless received written approval by the sponsor.
• Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery.
• Patient has an abdominal aortic artery lesion or aneurysm.
• Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament.
• Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery).
• Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral / tibial revascularization).
Device: Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, Device: Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
Peripheral Arterial Disease, Other Hematopoietic, Aortoiliac Occlusive Disease
UT Southwestern
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A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Daphne.Fuerte@UTSouthwestern.edu

Yu-Guang He
27714
All
60 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05811351
STU-2022-1055
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Inclusion Criteria:

• Have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area that can be measured and measures 2.5 millimeter square (mm^2) to 17.5 mm^2 (1- and 7- disc areas respectively), determined by the central reading center (CRC) from screening images of fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT)
• If GA is multifocal, at least one focal lesion must be greater than or equal to (>=)
• 25 mm^2 (0.5- disc area), as assessed by the CRC
• GA can be photographed in its entirety by FAF, using a 30- degree image centered on the fovea, as assessed by the CRC
• Fellow eye must be present with a best corrected distance visual acuity (BCVA) of counting fingers or better
• Man or woman (according to their reproductive organs and functions assigned by chromosomal complement)
Exclusion Criteria:

• History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye
• Any prior thermal laser in the macular region, regardless of indication
• History of retinal detachment (with or without repair)
• Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
• Any sign of diabetic retinopathy or central serous chorioretinopathy
Drug: JNJ-81201887, Drug: Prednisone, Other: Placebo, Drug: Triamcinolone, Other: Sham Procedure
Geographic Atrophy, Eye and Orbit
Macular Degeneration
UT Southwestern
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A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and axitinib, as compared to pembrolizumab and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC).

Call 833-722-6237
canceranswerline@utsouthwestern.edu

James Brugarolas
80679
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05805501
STU-2023-0549
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Inclusion Criteria:

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• International Metastatic RCC Database Consortium (IMDC) risk intermediate (score of 1 or 2) or poor (score of 3-6)
• Measurable disease with at least one measurable lesion
• Histologically confirmed ccRCC with or without sarcomatoid features
• Negative for HIV, hepatitis B, or hepatitis C virus (HCV)
Exclusion Criteria:

• Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 90 days after the final dose of tiragolumab, 4 months after the final dose of tobemstomig (RO7249669) and pembrolizumab, or for 1 week after the final dose of axitinib, whichever occurs last
• Inability to swallow a tablet or malabsorption syndrome
• Prior treatment for localized and/or metastatic RCC with systemic RCC-directed therapy, including T-cell costimulating or immune checkpoint blockade therapies
• Ongoing use or anticipated need for treatment with a strong CYP3A4/5 inhibitor or inducer
• Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
• Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• History of leptomeningeal disease
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• Moderate to severe hepatic impairment (Child-Pugh B or C)
• Uncontrolled hypertension
• Prior history of hypertensive crisis or hypertensive encephalopathy
• Significant cardiovascular/cerebrovascular disease within 3 months prior to randomization
• History of clinically significant ventricular dysrhythmias or risk factors for ventricular dysrhythmias
• History of congenital QT syndrome
• Resting heart rate (HR) > 100 bpm (or clinically significant tachycardia)
• Stroke (including transient ischemic attack), myocardial infarction, or other symptomatic ischemic event, or thromboembolic event (e.g., deep venous thrombosis [DVT], pulmonary embolism [PE]) within 3 months before randomization
• Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1
• Tumors invading pulmonary blood vessels, cavitating pulmonary lesions or known endobronchial disease
• Tumor invading the gastrointestinal (GI) tract, including abdominal or tracheoesophageal fistulas
• Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
• Active peptic ulcer disease, acute pancreatitis, acute obstruction of the pancreatic or biliary duct, appendicitis, cholangitis, cholecystitis, diverticulitis, gastric outlet obstruction
• Intra-abdominal abscess within 6 months before initiation of study treatment
• Clinical signs or symptoms of GI obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
• Evidence of bleeding diathesis or significant coagulopathy
• Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment
• Clinically significant hematuria, hematemesis, hemoptysis of > 0.5 teaspoon (2.5 mL) of red blood, coagulopathy, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 3 months before initiation of study treatment
• Active or history of autoimmune disease or immune deficiency
• Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
• Prior allogeneic stem cell or solid organ transplantation
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• History of another primary malignancy other than RCC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%)
• Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live, attenuated vaccine will be required during the study
• Active tuberculosis (TB)
• Severe infection within 4 weeks prior to initiation of study treatment
• Participants with active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
• Known hypersensitivity to Chinese hamster *ovary cell products or to any component of tobemstomig, tiragolumab, pembrolizumab, or axitinib
Drug: Tobemstomig, Drug: Tiragolumab, Drug: Pembrolizumab, Drug: Axitinib
Renal Cell Carcinoma
UT Southwestern
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Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other serious adverse reaction(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Kevin Courtney
131906
Male
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT05803941
STU-2023-0798
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Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study
• Must have received at least one dose of AAA617 within an interventional, Phase I-IV Novartis sponsored clinical trial in prostate cancer and have fulfilled the trial's requirements that allows them to participate in this study.
• Willingness of sexually active participant to use a condom during intercourse for up to 14 weeks from the last dose of AAA617 treatment administered on the parent study.
Exclusion Criteria:

• Inability to complete the needed investigational examinations due to any reason.
Drug: AAA617
Prostate Cancer, Prostate
Prostate Cancer, Long-Term Safety Follow-Up, 177Lu-PSMA-617, [177Lu]Lu-PSMA-617, lutetium (177Lu) vipivotide tetraxetan, AAA617, parent treatment study
UT Southwestern
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A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma

This study will be conducted in 2 parts. The first part is a phase 1 single-agent dose escalation,optimization, and expansion study of tegavivint in patients with advanced HCC after failure of at least one line of prior systemic therapy. In the second part of the study, the combination of tegavivint plus pembrolizumab will be assessed with a limited dose escalation followed by a randomized dose optimization.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

David Hsieh
171069
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05797805
STU-2023-0867
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Inclusion Criteria:

• Male or female, 18 years of age or older
• Confirmed diagnosis of HCC by either: Histologically or cytologically documented HCC based on pathology report or Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria
• Presence of AXIN1 or CTNNB1 mutation is required for all patients, except those enrolled in the single agent dose escalation Documentation of comprehensive genomic profiling to assess for mutations in β-catenin signaling including AXIN1 and CTNNB1 is required for all patients
• Ascertainment from fresh biopsy or liquid biopsy during screening is allowed.
• Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
• Child-Pugh class A or ≤ 7 class B liver score (no hepatic encephalopathy) within 7 days of first dose of the investigational product(s)
• Disease progression, intolerance or contraindication to at least one line of systemic therapy for advanced HCC Prior treatment with a PD-1/PD-L1 inhibitor for at least one administration
• Measurable disease as defined by RECIST 1.1
• Willingness and ability to provide tumor biopsies during screening and while on treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of the investigational product(s)
• Patients must have organ and marrow function as defined below within 7 days of the first dose of the investigational product(s):
• Absolute neutrophil count (ANC) ≥ 1.2 x 109/L
• Platelets ≥ 60 x 109/L; no transfusion within 7 days prior to assessment
• Hemoglobin ≥ 9 g/dL (red blood cell transfusion or growth factors support is not allowed in the 14 days prior to the screening laboratory assessment)
• Total bilirubin ≤ 2 mg/dL, or direct bilirubin ≤ upper limit of normal (ULN) for those with total bilirubin >2 mg/dL
• AST and ALT ≤ 5 x ULN
• Estimated creatinine clearance (CrCl) by the Cockcroft-Gault equation or measured ≥ 60 mL/min.
• Albumin ≥ 3.0 g/dL
• International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
• Washout period prior to Day 1 of Cycle 1:
• At least 21 days from the last dose of prior systemic anticancer treatment
• At least 14 days from palliative radiotherapy (≤ 10 fractions or ≤30 gray [Gy] total dose or at least 28 days from radiotherapy > 30 Gy)
• Grade ≤ 1 toxicity due to any previous cancer therapy according to the NCI-CTCAE, v.5.
• Grade 2 is allowed in case of alopecia and/or peripheral sensory neuropathy.
• Participants with past HCV infection will be eligible for the study. The treated participants must have completed their treatment at least 1 month prior to starting study intervention and HCV viral load must be below the limit of quantification.
• Participants with controlled HBV will be eligible if they meet the following criteria:
• Antiviral therapy for HBV must be given for at least 4 weeks and HBV viral load must be less than 500 IU/mL prior to first dose of study drug. Patients on active HBV therapy with viral loads under 100 IU/mL should stay on the same therapy throughout study intervention.
• Patients who are positive for anti-hepatitis B core antibody HBc, negative for hepatitis B surface antigen (HBsAg), and negative or positive for anti-hepatitis B surface antibody (HBs), and who have an HBV viral load under 100 IU/mL, do not require HBV antiviral prophylaxis.
• Patients must have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤ 150/90 mm Hg at Screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1.
Exclusion Criteria:

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
• Patients receiving therapy with other anti-neoplastic or experimental agents
• Patients receiving concomitant strong inhibitors of CYP3A4/5 that cannot be discontinued 7 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
• Patients receiving concomitant inducers of CYP3A4/5 that cannot be discontinued at least 14 days prior to Cycle 1 Day 1.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to tegavivint, or other agents used in study
• Malignant disease, other than that being treated in this study. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded. Other exceptions include malignancies that were treated curatively and have not recurred within 3 years prior to Cycle 1 Day 1 and any malignancy considered indolent and that has never required therapy.
• Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
• Known central nervous system (CNS) involvement
• Uncontrolled concurrent illness including, but not limited to:
• Ongoing or active infection (exception: HBV infection - see inclusion criteria)
• Unhealed wounds or presence of any external drainage
• Psychiatric illness/social situations that would limit compliance with study requirements; discuss with Medical Monitor if there are any questions
• Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
• Congestive heart failure, NYHA > Class II
• Left ventricular ejection fraction < 50%
• Unstable angina pectoris or cardiac arrhythmia
• Baseline QTc (Fridericia) ≥ 450 milliseconds. In the event a QTc (Fridericia) measurement is not possible due to factors such as a pacemaker or bundle branch block, the patient may be evaluated by a cardiologist who must document no apparent increased risk for Torsades de Point or other morbidity associated with prolonged QTc. With such documentation, the patient may be eligible based with additional Medical Monitor review.
• Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome
• Myocardial infarct within 6 months before Cycle 1 Day 1
• Clinically significant pericardial disease
• Any major surgery within 21 days prior to Cycle 1 Day 1. Major surgery is defined as any significantly invasive procedure into a major body cavity (abdomen, cranium etc.) and/or surgery requiring extensive recuperation (joint replacement). Please discuss with the Medical Monitor if there are any questions.
• Pregnant and breastfeeding women are excluded from this study. The effects of tegavivint on the developing human fetus have the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with tegavivint
• Women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use one highly effective method of contraception, including hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device or intrauterine system; vasectomy or tubal ligation; and one effective method of contraception, including male condom, female condom, cervical cap, diaphragm or contraceptive sponge or abstaining from sex for the duration of study participation and for at least 4 months following completion of tegavivint and pembrolizumab (if applicable) administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for PK interactions with tegavivint.
• Exclusions for patients treated on study with pembrolizumab:
• Have received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
• Have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• Have active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
• Have a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or have current pneumonitis/interstitial lung disease.
• Prior allogeneic organ or bone marrow transplant
Drug: Tegavivint, Drug: Pembrolizumab
Advanced Hepatocellular Carcinoma, Liver
UT Southwestern; Parkland Health & Hospital System
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Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance (ReplaceCysto)

The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with urine testing. Specifically, this study examines whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Yair Lotan
59883
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05796375
STU-2023-0996
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Inclusion Criteria:

• Aged 18 years or older
• History of low grade intermediate-risk non-muscle invasive bladder cancer, defined as most recent pathology report showing any of the following:
• multifocal low grade non-invasive urothelial carcinoma of any size
• solitary low grade non-invasive urothelial carcinoma greater than 3cm in size
• recurrent low grade non-invasive urothelial carcinoma
• Stated willingness to comply with all study procedures and availability for the duration of the study
• No evidence for recurrence at cystoscopy ≤4 months after most recent tumor resection
• Ability to consent in English or Spanish
Exclusion Criteria:

• History of total cystectomy of the bladder.
• History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit).
• History of muscle-invasive bladder tumor.
• Pregnancy or lactation.
• History of urothelial carcinoma of the ureter or renal pelvis status post endoscopic treatment or with evidence of recurrent upper tract disease (inclusion allowed if status post nephroureterectomy and recurrence free at time of inclusion)
• Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).
• Inability to provide a voided urine sample.
Procedure: Cystoscopy, Diagnostic Test: Bladder EpiCheck urine test, Diagnostic Test: Xpert Bladder Cancer Monitor urine test
Urinary Bladder, Non-muscle-invasive Bladder Cancer
Bladder, Cancer, Urology, Cystoscopy, Xpert, EpiCheck, Urine test
UT Southwestern
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Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies

This study is a first-in-human (FIH), Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Tian Zhang
206021
All
18 Years to 100 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT05783622
STU-2023-0808
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Inclusion Criteria:

• Subjects ≥18 years of age at the time of signing informed consent
• Histologically or cytologically documented locally advanced or metastatic NSCLC, SCCHN, CRC, or RCC
• Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for the tumor type
• Adequate organ function
• At least 1 measurable lesion per RECIST 1.1
Exclusion Criteria:

• Treatment with anti-cancer therapy within 28 days or ≤5 elimination half-lives, whichever is earlier, before enrollment
• Prior treatment with EGFR-targeted bispecific T cell engager or CAR-T cell therapy
• Prior treatment with CD3 engaging bispecific antibodies
• Clinically significant cardiovascular diseases
• Active clinically significant infection (bacterial, viral, fungal, mycobacteria, or other)
• On supplemental oxygen
• Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
Drug: JANX008
Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Colorectal Carcinoma, Colon, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Lung/Thoracic, Rectum, Squamous Cell Carcinoma of the Head and Neck
UT Southwestern
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First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuria

The goal of Parts A and B of this Phase 1, first-in-human, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of single (SAD) and multiple (MAD) ascending doses of oral JNT-517 in healthy participants. In Part C, the goal is to evaluate the differences in bioavailability between a tablet and suspension formulation of JNT-517 and the food effect in healthy volunteers. All participants in Part C will receive JNT-517. The goal of Part D is to assess the safety, tolerability, PK, and effect on urinary Phe and other amino acids of JNT-517 in participants with phenylketonuria (PKU). Participants in Part D will receive either JNT-517 or placebo and will be blinded to their treatment assignment. The study consists of 4 parts: - Part A: SAD in healthy participants -randomized, double-blind, placebo-controlled - Part B: MAD in healthy participants (14 days)-randomized, double-blind, placebo-controlled - Part C: Relative bioavailability of 2 formulations and food effect in healthy participants-randomized, open-label - Part D: Phase 1b in participants with PKU (4 weeks)-randomized, double-blind, placebo-controlled In each part, participants will complete a Screening Period, a Treatment Period, and a Follow-up Period for safety.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Juana.Luevano@UTSouthwestern.edu

Markey McNutt
59152
All
18 Years to 65 Years old
Phase 1
This study is also accepting healthy volunteers
NCT05781399
STU-2023-0090
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Key
Inclusion Criteria:
Parts A, B, and C:
• Males and females 18 to 55 years of age.
• Medically healthy with no clinically significant medical history.
• Body mass index (BMI) of 18-40 kg/m2 and total body weight >50 kg (110 lbs).
• Non-smoker for at least 2 weeks prior to dosing and willing to abstain during the study. Part D:
• Males and females 18 to 65 years of age, inclusive.
• Diagnosis of PKU with a confirmed genotype.
• At least 2 plasma Phe levels >600 μM over the past 12 months.
• BMI of 18-40 kg/m2. All Parts:
• Females of childbearing potential must agree to use 2 highly effective contraceptive methods.
• Capable of giving signed informed consent and able to comply with study procedures. Key
Exclusion Criteria:
All Parts:
• Any acute or chronic medical condition that would prevent the participant from complying with the procedures or place the participant at risk if they participate in the study.
• Positive for hepatitis B or C or human immunodeficiency virus.
• Any history of malignancy in the last 5 years, excluding non-melanoma skin cancer.
• Any history of liver disease.
• Any surgical or medical conditions that may affect study drug absorption, distribution, metabolism, or excretion.
• Participation in another investigational drug trial within 30 days or, if known, 5 half-lives of the investigational drug (whichever is longer).
• History of drug/alcohol abuse in the last year.
• Current, recent, or suspected infection within 4 weeks of Screening of SARS-CoV-2/COVID-19.
• Received a vaccine for SARS-CoV-2/COVID-19 within 14 days of Screening.
• Unable to tolerate oral medication.
• Allergy to JNT-517 or any component of the investigational product.
• Received >50 mL of blood or plasma within 30 days of Screening or >500 mL of blood or plasma within 60 days of Screening.
Drug: JNT-517 Suspension, Drug: Placebo Suspension, Drug: JNT-517 Tablet, Drug: Placebo Tablet
Other Endocrine System, Phenylketonuria
PKU
UT Southwestern
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A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies

This clinical trial is evaluating a drug called AC676 in participants with Relapsed/Refractory B-cell Malignancies. The main goals of the study are to: - Identify the recommended dose of AC676 that can be given safely to participants - Evaluate the safety profile of AC676 - Evaluate the pharmacokinetics of AC676 - Evaluate the effectiveness of AC676

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Farrukh Awan
180091
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05780034
STU-2023-0813
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Inclusion Criteria:

• Adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF).
• Patients with histologically confirmed relapsed/refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), non-GCB Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), or Waldenström Macroglobulinemia (WM).
• Must have received at least 2 prior systemic therapies or have no other therapies to provide significant clinical benefit in the opinion of the Investigator or who are not amenable (intolerability, patient choice) to standard therapies.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from study entry:
• Treatment with any of the following:
• Small molecule anti-cancer drugs within 5 half-lives or 2 days (whichever is longer, not to exceed 14 days).
• Systemic chemotherapy within 14 days.
• Radiation therapy within 14 days
• Biologics (Antibodies) treatment within 28 days,
• Radioimmunoconjugates or toxin conjugates within 12 weeks.
• Prior Chimeric antigen receptor (CAR) T cell therapy (and prior use of immunoglobulin replacement therapy to treat associated adverse events) within 3 months. For patients with DLBCL, no prior CAR- T therapy is allowed.
• Autologous or allogenic stem cell transplant within 100 days and must not have ongoing graft-versus-host disease (GVHD) and no ongoing therapy to treat GVHD.
• History of central nervous system lymphoma/leukemia in remission for less than 2 years.
• Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.
Drug: AC676
Non-Hodgkins Lymphoma, Relapsed/Refractory B-cell Malignancies
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), Non-Germinal Center B-cell (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL, Waldenström Macroglobulinemia (WM), Non-Hodgkin Lymphoma (NHL), Bruton's tyrosine kinase-BTK, BTK Degrader, AC676, AC0676
UT Southwestern
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Safety and Clinical Activity of KT-253 in Adult Patients With High Grade Myeloid Malignancies, Acute Lymphocytic Leukemia, Lymphoma, Solid Tumors

This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and clinical activity of KT-253 in adult patients with relapsed or refractory (R/R) high grade myeloid malignancies, acute lymphocytic leukemia (ALL), R/R lymphoma, and R/R solid tumors. The study will identify the pharmacologically optimal dose(s) of KT-253 as the recommended Phase 2 dose (RP2D), based on all safety, PK, PD, and efficacy data.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Yazan Madanat
187698
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05775406
STU-2023-0679
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Inclusion Criteria:

• All Participants:
• Eastern Cooperative Oncology Group performance status: 0-2.
• Resolved acute effects of any prior therapy except for alopecia to baseline severity or Grade ≤1 NCI CTCAE and Grade ≤2 neuropathy
• Adequate organ function at screening
• Solid Tumors and Lymphoma (Arm A) ONLY
• Histologically or pathologically confirmed solid tumor or lymphoma.
• Relapsed and/or refractory (R/R) disease to at least two prior standard-of-care treatments or tumors for whom standard therapies are not available.
• Advanced high grade myeloid malignancies, and Acute Lymphocytic Leukemia (Arm B) ONLY
• Primary diagnosis of AML, ALL, High/Very High-risk MDS, MDS/MPN. Must be relapsed/refractory to standard therapies.
Exclusion Criteria:

• All Participants:
• Ongoing unstable cardiovascular function.
• Major surgery requiring general anesthesia within 4 weeks prior to first dose of study drug.
• History of or active concurrent malignancy unless disease-free for ≥ 2 years.
• Exposures to anticancer therapy within 2 weeks or 5 half-lives whichever is shorter; or 4 weeks from any biologics/immunotherapies or any investigational therapy prior to the first dose of study drug.
• Known presence of p53 mutation in tumor tissue
• Solid Tumors and Lymphoma (Arm A) ONLY
• Known active uncontrolled or symptomatic central nervous system (CNS) metastases.
• Autologous or allogenic hematopoietic stem cell transplant (HSCT) within six months prior to first dose of study drug or participant has progressed within six months from the day of stem cell infusion (for lymphoma participants only).
• Advanced high grade myeloid malignancies, and ALL (Arm B) ONLY
• Active CNS leukemia. Participants with symptoms suggestive of CNS disease will require a lumbar puncture to rule out CNS disease.
• Prior chemotherapy/radiation (including craniospinal radiation) within 2 weeks prior to the first dose of study drug.
• Received allogeneic hematopoietic cell transplantation (HCT) <12 weeks prior to first dose or donor lymphocyte infusion (DLI) without conditioning <4 weeks prior to first dose.
• Received autologous stem cell transplant (ASCT) < 4 weeks prior to first dose or the patient has not recovered from transplant associated toxicities to ≤ grade 1 prior to the first dose of study drug.
• Received chimeric antigen receptor therapy or other modified T cell therapy <3 weeks prior to the first dose.
• Patients with signs or symptoms of Grade ≥ 2 acute or chronic graft versus host disease (GVHD) within 2 weeks of enrollment.
Drug: KT-253
Multiple Myeloma, Advanced Solid Tumors, Acute Lymphocytic Leukemia, Eye and Orbit, Anus, Bones and Joints, Breast - Female, Breast - Male, Cervix, Colon, Esophagus, Kidney, Larynx, Liver, Lung/Thoracic, Ovary, Pancreas, Prostate, Rectum, Stomach, Thyroid, Leukemia, Other, Leukemia, Not Otherwise Specified, Lymphoid Leukemia, Myeloid and Monocytic Leukemia, Myeloid Malignancies, Lymphomas
KT-253, MDM2, High Grade MDS/MPN, ALL, AML, Lymphoma, Solid tumor
UT Southwestern
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Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients (SAFE KIDNEY II)

The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in Kidney Transplant Recipients (KTRs). The study includes two parts. The phase II part will evaluate the safety of AntiBKV in KTRs and establish proof of concept. The phase III part will assess the efficacy of AntiBKV in KTRs. For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of placebo (every 4 weeks). Both the phase II and phase III parts will follow identical study assessments and schedules for participants. Based on an interim analysis after phase II total sample size for the trial will be defined. Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a 4-week interval. Seven days following the first IMP administration, participants will be re-evaluated for BKV DNAemia and, if appropriate, changes of immunosuppressive treatment will be started. After administration of the final dose, participants will return as out participants for periodic safety, BKV DNAemia, and PK follow-up assessments until the end of the trial visits, 26 weeks post last IMP application. Regular kidney biopsies will be performed at baseline (prior to infusion) and on Day 141 (8 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and as clinically indicated.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Elaine.Bonilla@UTSouthwestern.edu

David Wojciechowski
188709
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT05769582
STU-2023-0350
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Inclusion Criteria:

• Male or female aged 18 years or older
• Kidney transplantation within 24 months prior to enrollment
• Kidney transplant recipient with first-time BKV DNAemia (evaluated during routine clinical monitoring by the local laboratory and acknowledged by a physician within 4 months prior to Day 1). BKV DNAemia is either defined by BKV-DNAemia of one time >10,000 copies/mL, or >1,000 copies/mL sustained for at least one week (confirmed by 2 consecutive measurements. Note: The second, most recent laboratory value must be acknowledged by a physician within 4 months prior to Day 1)
• Kidney transplant recipients with adequate and/or stable allograft function as indicated by estimated glomerular filtration rate ((e)GFR) ≥ 30 mL/min
• Female subjects (if of childbearing potential) must agree to use adequate and reliable contraceptive measures throughout their participation in the trial. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Ability to provide written informed consent
Exclusion Criteria:

• Patients with previous diagnosis of BK viremia (defined as one time >10,000 copies/mL, or >1,000 copies/mL sustained for at least one week (confirmed by 2 consecutive measurements) since last kidney transplant
• Known hypersensitivity to any component of the investigational medicinal product (IMP)
• Transplanted kidney disease with an estimated glomerular filtration rate ((e)GFR) < 30 mL/minute at screening
• Uncontrolled acute or chronic infection other than BK virus (BKV) infection at screening which might interfere with study participation at the discretion of the investigator
• Recipients who are treated or planned to be treated with a mammalian Target of Rapamycin (mTOR) inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the study period.
• Recipients who are treated or planned to be treated during study participation with leflunomide at the time of enrollment and during the study period.
• Recipients who in the opinion of the investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depleting therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg)
• Recipients with active kidney transplant rejection or focal segmental glomerulosclerosis (FSGS) shown by renal biopsy
• Recipients who have medical conditions or receive concomitant medications that prevent the recipient from undergoing allograft biopsy
• Recipients with known donor-specific antibodies (DSA) (de novo or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (<1000 mean fluorescence intensity (MFI) can be includred if no impact on the study assessments is expected by the discretion of the investigator
• Recipients with extremely high BK virus (BKV)-DNAemia (>10,000,000 copies/mL) or hemorrhagic cystitis
• Recipients who in the opinion of the investigator are likely to develop recurrent native kidney disease (e.g. immunoglobulin A [IgA] nephritis, focal segmental glomerulosclerosis [FSGS], C3 glomerulonephritis)
• Recipients with a functionally significant ureteral stricture
• Pregnant or nursing (lactating) women
• Known current active or latent TB or any history, in the opinion of the investigator, that confers a risk of reactivation of latent TB and precludes the use of conventional immunosuppression
• History of splenectomy or asplenia
• Any condition, that in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of the participant safety data or study results
• History of malignancy within the past 5 years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least 2 years prior to screening
• Participation in another interventional clinical trial during trial participation or within 30 days prior to the investigational medicinal product (IMP) dosing or planned dosing
• History of alcoholism or drug addiction within 1 year of screening. Substance use disorder will be an exclusion criterion, at investigator's discretion
Biological: Anti-BK polyomavirus (AntiBKV)
BK Viremia, BKV DNAemia
UT Southwestern
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Phase 1/2 Study of AOC 1020 in Adults With Facioscapulohumeral Muscular Dystrophy (FSHD) (FORTITUDE)

A Randomized, Double-blind, Placebo-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of AOC 1020 Administered Intravenously to Adult Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)

Call 214-648-5005
studyfinder@utsouthwestern.edu, Tara.Kristof@UTSouthwestern.edu

Jaya Trivedi
46764
All
18 Years to 65 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05747924
STU-2022-1177
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Inclusion Criteria:

• FSHD1 or FSHD2 diagnosis confirmed by documented genetic testing (testing provided by Sponsor)
• Ambulatory and able to walk 10 meters (with or without assistive devices such as one cane, walking stick or braces)
• At least 1 muscle region suitable for biopsy (testing provided by Sponsor)
• Muscle weakness in both upper and lower body, as determined by Investigator
Exclusion Criteria:

• Diagnosed with congenital or infantile FSHD
• Pregnancy, intent to become pregnant within 9 months after last planned dose of Study Drug, or active breastfeeding
• Unwilling or unable to continue to comply with contraceptive requirements
• Body mass index (BMI) >35.0 kg/m2 at Screening
• History of muscle biopsy within 30 days of the screening biopsy or planning to undergo any nonstudy muscle biopsies over the duration of the study
• History of bleeding disorders, significant keloid, or other skin or muscle conditions (e.g., severe muscle wasting) that, in the opinion of the Investigator, makes the participant unsuitable for serial muscle biopsy
• Anticipated survival less than 2 years
• Blood or plasma donation within 16 weeks of Study Day 1
• Any contraindication to MRI
• Any abnormal lab values, conditions or diseases that, in the opinion of the investigator or Sponsor, would make the participant unsuitable for the study or could interfere with participation or completion of the study
• Treatment with any investigative medication within 1 month (or 5 half-lives of the drug, whichever is longer) of Screening
Drug: AOC 1020, Drug: Placebo
Muscular Dystrophies, FSHD, FSHD1, FSHD2, FMD, FMD2, Fascioscapulohumeral Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy Type 1, Fascioscapulohumeral Muscular Dystrophy Type 2, Dystrophies, Facioscapulohumeral Muscular, Dystrophy, Facioscapulohumeral Muscular, Facioscapulohumeral Muscular Dystrophy 1, Facioscapulohumeral Muscular Dystrophy 2, Facio-Scapulo-Humeral Dystrophy, Atrophy, Facioscapulohumeral, Atrophies, Facioscapulohumeral, Facioscapulohumeral Atrophy, Muscular Dystrophy, Facioscapulohumeral, FSH Muscular Dystrophy, Landouzy Dejerine Dystrophy, Landouzy-Dejerine Muscular Dystrophy, Dystrophies, Landouzy-Dejerine, Dystrophy, Landouzy-Dejerine, Landouzy-Dejerine Syndrome, Muscular Dystrophy, Landouzy Dejerine, Progressive Muscular Dystrophy, FSH
FORTITUDE, Avidity, Avidity Biosciences, AOC 1020
UT Southwestern
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ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE (ARTEMIS)

The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.

Call 214-648-5005
studyfinder@utsouthwestern.edu, salina.shrestha@utsouthwestern.edu

Michael Jessen
13574
All
18 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05746559
STU-2023-0186
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Inclusion Criteria:

• Participant weighs ≥ 30 kg
• Planned non-emergent sternotomy with CPB procedure for the following surgeries:
• Multi-vessel CABG
• Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair
• Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted
• Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4)
Exclusion Criteria:

• Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator.
• Single-vessel CABG without valve surgery is planned.
• Off-pump surgery is planned (eg, surgery without CPB).
• Recipient of a solid organ or bone marrow transplantation.
• Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.
• Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
• History of unexplained, recurrent infection.
• Any use of KRT or presence of AKI within 30 days of randomization
• Use of any complement inhibitors, or plasmapheresis or plasma exchange within the year prior to Screening, or planned use during the course of the study.
• Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics, if needed
• History of or unresolved N meningitidis infection.
Drug: Placebo, Drug: Ravulizumab
Cardiopulmonary Bypass, Chronic Kidney Disease, Kidney, Cardiac Disease, CKD
Chronic Kidney Disease, CKD, Cardiac Disease, cardiopulmonary bypass
UT Southwestern
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Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)

A multi-center, placebo-controlled, double blind, 1:1:1 randomized control clinical trial testing two different JAK Inhibitors abrocitnib, ritlecitinib, and placebo in subjects with recent onset Stage 3 Type 1 Diabetes within 100 days of diagnosis.

Call 214-648-5005
studyfinder@utsouthwestern.edu, Michelle.Murphy@UTSouthwestern.edu

Perrin White
17917
All
12 Years to 35 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT05743244
STU-2023-1068
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Inclusion Criteria:

• Provide informed consent or assent as appropriate and, if < 18 years of age have a parent or legal guardian provide informed consent
• Age 12-35 years (both inclusive) at the time of signing informed consent and assent
• Diagnosis of T1D within 100 days of the baseline visit (V0).
• Positive for at least one islet cell autoantibody; Glutamate decarboxylase (GAD)65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A
• Stimulated C-peptide of ≥0.2 pmol/mL measured during mixed-meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes
• HbA1c ≤ 10 %
• Body weight ≥ 35kg at screening
• Willing to comply with intensive diabetes management and wear a Continuous Glucose Monitoring Device (CGM)
• Participants who are Cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) seronegative at screening must be CMV and/or EBV Polymerase chain reaction (PCR) negative within 30 days of randomization and may not have had signs or symptoms of a CMV and/or EBV-compatible illness lasting longer than 7 days within 30 days of the baseline visit (V0).
• Be up to date on recommended immunizations; participants are required to receive killed influenza vaccination at least 2 weeks prior to the baseline visit (V0) when vaccine for the current or upcoming flu season is available. Enrollment must be delayed at least 4 weeks from administration of a killed vaccine other than influenza and 6 weeks from a live vaccination. Vaccinations should not be given while on study drug and be postponed at least 3 months after the last dose of study drug.
• Participants are required to be fully vaccinated including eligible boosters and should receive an authorized non-live COVID-19 vaccination series or COVID-19 vaccine at least 2 weeks prior to the baseline visit (V0).
• If participant is female with reproductive potential, she must have a negative pregnancy test at screening and be willing to avoid pregnancy using a highly-effective contraceptive method for the duration of the study
• Males of reproductive age must use a highly-effective contraceptive method during the treatment phase and for 3 months following last dose of study drug
Exclusion Criteria:

• Current or ongoing use of non-insulin pharmaceuticals or medication that affect glycemic control or glucose homeostasis within 7 days prior to screening or any prohibited concomitant medication listed in section 4.8
• Untreated hypothyroidism or active Graves' disease
• Concurrent treatment with other immunosuppressive agents (including biologics or steroids), other than inhaled or topical glucocorticoids
• Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 1 month prior to Day 0 or superficial skin infection within 1 week prior to Day 0
• Active acute or chronic infection requiring treatment with intravenous therapy (IV) within a minimum 1 month prior to Day 0 a. Specific cases should be reviewed by Infectious Disease Committee prior to enrollment
• Have active signs or symptoms of acute infection at the time of the baseline visit (V0).
• Significant trauma or major surgery within 1 month of signing informed consent.
• Considered in imminent need for surgery or with elective surgery scheduled to occur during the study
• History of disseminated herpes zoster or disseminated herpes simplex or a recurrent (more than one episode of) localized, dermatomal herpes zoster
• Have evidence of prior or current tuberculosis infection as assessed by Purified Protein Derivative (PPD), interferon gamma release assay (IGRA) or by history
• Have evidence of current or past HIV or Hepatitis B infection
• Have evidence of active Hepatitis C infection
• Have current, confirmed COVID-19 infection
• Current or history of Deep vein thrombosis (DVT), Pulmonary embolism (PE), or other thromboembolic events or history of inherited coagulopathies
• First degree relative with a history of unprovoked venous thromboembolism (i.e. without known underlying cause such as trauma, surgery, immobilization, prolonged travel, pregnancy, hormone use, or plaster cast), which suggests that a participant may be at increased risk of inherited coagulation disorder
• Any present malignancies or history of malignancy, other than a successfully treated nonmelanoma skin cancer
• History of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease
• Known or suspected polymorphism in the Cytochrome P450 2C19 (CYP2C19 gene, resulting in classification as a poor CYP2C19 metabolizer).
• Have renal impairment (eGFR< 60 mL/min)
• Currently on anti-platelet therapies, excluding low dose aspirin
• One or more screening laboratory values as stated
• Neutrophils < 1,500 /μL
• Lymphocytes < 800 /μL
• Platelets < 150,000 / μL
• Hemoglobin < 6.2 mmol/L (10.0 g/dL)
• Potassium > 5.5 mmol/L or <3.0 mmol/L
• Sodium > 150mmol/L or < 130mmol/L
• AST or ALT ≥ 2.5 times the upper limit of normal
• Bilirubin ≥ 1.5 times upper limit of normal unless diagnosed with Gilbert's syndrome
• LDL >160 mg/dL
• Vaccination with a live virus within the last 6 weeks and killed vaccine within 4 weeks (except 2 weeks for flu vaccine and COVID vaccine)
• Be currently pregnant or lactating or anticipate becoming pregnant during the study
• Male participants able to father children and female participants of childbearing potential who are unwilling or unable to use 2 effective methods (at least 1 highly effective method) of contraception, including abstinence, as outlined in this protocol for the duration of the study and for at least 3 months after the last dose of investigational product
• Be currently participating in another T1D treatment study
• Have hearing loss with progression over the previous 5 years, or sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating, or progressive
• Acute coronary syndrome (e.g., myocardial infarction, unstable angina pectoris) and any history of cerebrovascular disease within 24 weeks before screening; Heart failure NYHA (New York Heart Association) III, NYHA IV
• ANY of the following conditions at screening: a. Screening 12-lead electrocardiogram (ECG) that demonstrates: i. Clinically significant abnormalities requiring treatment (eg, acute myocardial infarction, serious tachy- or brady-arrhythmias) or indicating serious underlying heart disease (eg, cardiomyopathy, Wolff-Parkinson- White syndrome); ii. Confirmed QT corrected using Fridericia's correction factor (QTcF) prolongation (>450 milliseconds). b. Long QT Syndrome, a family history of Long QT Syndrome, or a history of Torsades de Pointes (TdP).
• History of chronic alcohol abuse or intravenous drug abuse or other illicit drug abuse within 2 years prior to screening
• Current or past use of tobacco or nicotine containing products more than the equivalent of 5 cigarettes per day
• Participant is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the trial
• Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk
• Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
Drug: Abrocitinib 200 MG Oral Tablet, Drug: Ritlecitinib, Drug: Placebo
Diabetes Mellitus, Type 1, Pancreas
TrialNet, T1D
UT Southwestern; Children’s Health
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A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, or 7+3 in Patients With AML

This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Yazan Madanat
187698
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05735184
STU-2023-0858
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Key
Inclusion Criteria:

• Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Adequate liver, renal, and cardiac function according to protocol defined criteria
• A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention Key
Exclusion Criteria:

• Diagnosis of either acute promyelocytic leukemia or blast chronic myelomonocytic leukemia
• Known history of BCR-ABL alteration
• Advanced malignant hepatic tumor [for patients receiving ven/aza combination]
• Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery
• Active central nervous system (CNS) involvement by AML.
• Clinical signs/symptoms of leukostasis or WBC > 25,000 / microliter. Hydroxyurea and/or leukapheresis are permitted to meet this criterion
• Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia
• Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
• For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and/or leukapheresis to control leukocytosis, prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia, or non-HMA therapy for prior myelodysplastic syndrome
• For relapsed/refractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational < 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug
• Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol
• Mean corrected QT interval corrected for heart rate by Fredericia's formula (QTcF) >480 ms on triplicate ECGs
• Uncontrolled infection
• Women who are pregnant or lactating
• An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled/progressing
Drug: Ziftomenib, Drug: Venetoclax, Drug: Azacitidine, Drug: Daunorubicin, Drug: Cytarabine
Acute Myeloid Leukemia, Myeloid Sarcoma, Mixed Phenotype Acute Leukemia, Mixed Lineage Acute Leukemia, Acute Myeloid Leukemia, in Relapse, Mixed Lineage Leukemia Gene Mutation, Refractory AML, AML With Mutated NPM1, Acute Myeloid Leukemia Recurrent, NPM1 Mutation, KMT2Ar
UT Southwestern
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Domvanalimab and Zimberelimab in Advanced Liver Cancers

The goal of this clinical trial is to learn about advanced liver and bile duct cancers. The main question it aims to answer is: If the combination of Domvanalimab and Zimberelimab are effective in treating advanced hepatobiliary cancers that have failed prior treatment.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

David Hsieh
171069
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05724563
STU-2022-1076
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Inclusion Criteria:

• Patient must have a histologically confirmed diagnosis consistent with HCC or bile duct cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers); known fibrolamellar HCC, or combined HCC-cholangiocarcinoma will be excluded.
• Locally advanced or metastatic disease
• 2a. Patients with locally advanced or metastatic disease must have disease deemed not amenable to surgical and/or locoregional therapies or patients who have progressed following surgical and/or locoregional therapies.
• 2b. Measurable disease, as defined as lesions that can accurately be measured in at east one dimension according to RECIST version 1.1 at least 1 cm with contrast enhanced dynamic imaging (magnetic resonance imaging or computed tomography).
• Refractory to or relapsed after prior anti-PD-1/L1 antibody therapy. May have received anti-PD-1/L1 monotherapy or combination therapy as any line of therapy including in the neoadjuvant or adjuvant setting. Patients who discontinued prior immune checkpoint inhibitor treatment due to toxicity are not eligible.
• Availability of recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or slides in which the biopsy or resection was performed within 3 years. Baseline tissue can be obtained after consent but must be prior to initiation of zimberelimab and domvanalimab. It is strongly recommended that tissue is obtained from biopsies confirming progression of disease on prior therapy so that the patient has not received any intervening systemic anti-cancer treatment from the time that the baseline tissue was obtained.
• Prior locoregional is allowed provided the following are met: 1) at least 2 weeks since prior locoregional therapy including surgical resection, chemoembolization, radiotherapy, or ablation; 2) target lesion has increased in size ≥25% or the target lesion was not treated with locoregional therapy. Patients treated with palliative radiotherapy for symptoms will be eligible as long as the target lesion is not the treated lesion and radiotherapy will be completed at least 2 weeks prior to study drug administration.
• Age ≥ 18 years
• Child-Pugh Score A or B7-8 (only for Cohort A)
• ECOG Performance score of 0-1
• Adequate organ and marrow function (without chronic, ongoing growth factor support or transfusion in the last 2 weeks) as defined below:
• 9a. Platelet count ≥ 50,000/mm^3
• 9b. Hgb ≥ 8.5 g/dl
• 9c. Absolute neutrophil ≥ 1,000 cells/mm^3
• 9d. Total bilirubin ≤ 3.0 mg/ml (This will not apply to subjects with Gilbert's syndrome who have persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis, and such patients may be enrolled based in consultation with the principal investigator).
• 9e. INR ≤ 2
• 9f. AST, ALT ≤5 times ULN
• 9g. Calculated creatinine clearance (CrCl) ≥ 40 mL/min. CrCl can be calculated using the Cockroft-Gault method.
• 9h. Albumin ≥ 2.0 g/dl
• All men, as well as women of child-bearing potential, defined as not surgically sterilized and between menarche and 1-year post menopause, must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 4 weeks prior to study entry, for the duration of study participation, and for 120 days after the last dose of zimberelimab or domvanalimab. See contraception guidelines in Appendix 1. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Women of child-bearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication
• Subjects are eligible to enroll if they have non-viral-HCC, or if they have HBV-HCC, or HCV-HCC defined as follows:
• 1. HBV-HCC: Hepatitis B subjects will be allowed if they meet the following criteria: On antiviral therapy for HBV or HBV viral load must be less than 100 IU/mL prior to first dose of study drug. Subjects on active HBV therapy with viral loads under 100 IU/ml should stay on the same therapy throughout study treatment. Subjects who are anti-HBc (+), negative for HBsAg, negative for anti-HBs, and have an HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis.
• 2. HCV-HCC: Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody. Patients who have failed HCV therapy as evidenced by detectable HCV RNA will be eligible. Subjects with chronic infection by HCV who are treated (successfully or treatment failure) or untreated are allowed on study. In addition, subjects with successful HCV treatment are allowed as long as there are ≥4 weeks between completion of HCV therapy and start of study drug. Successful HCV treatment definition: SVR12.
• Ability to understand and the willingness to sign a written informed consent.
• Willing and able to comply with the requirements and restrictions in this protocol.
• Patients who have received the vector, protein subunit, or nucleic acid COVID-19 vaccines are eligible to enroll.
Exclusion Criteria:

• Prior liver transplant.
• Known human immunodeficiency virus (HIV) positive (testing not required).
• Use of any live vaccines against infectious diseases within 28 days of first dose of study drug administration.
• History of trauma or major surgery within 28 days prior to the first dose of study drug administration. (Tumor biopsy or placement of central venous access catheter (eg, port or similar) is not considered a major surgical procedure).
• Underlying medical conditions that, in the investigator's opinion, will make the administration of study drugs hazardous, including but not limited to:
• 5a. Interstitial lung disease, including history of interstitial lung disease or non infectious pneumonitis (lymphangitic spread of cancer is not disqualifying),
• 5b. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of study drugs,
• 5c. Clinically significant cardiovascular disease,
• 5d. A condition that may obscure the interpretation of toxicity determination or AEs,
• 5e. History of prior solid-organ transplantation.
• Hypersensitivity to IV contrast; not suitable for pre-medication.
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
• Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
• 8a. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
• 8b. Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study. Participants on chronic systemic corticosteroids will be excluded from the study.
• Known history of active bacillus tuberculosis.
• Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of study administration. Inhaled or topical steroids and adrenal replacement doses ≤10 mg/day prednisone equivalents are permitted in the absence of autoimmune disease.
• Known severe hypersensitivity reactions to monoclonal antibodies (≥Grade 3).
• Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer.
• Prisoners or subjects who are involuntarily incarcerated.
• If a participant has symptomatic or clinically active brain metastases including leptomeningeal disease, they must be excluded if:
• Has evidence of progression by neurologic symptoms
• Has metastatic brain lesions that require immediate intervention.
• Has carcinomatous meningitis, regardless of clinical stability
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Has significant dementia or other mental condition that precludes the participant's ability to consent to the study.
• Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drugs.
• Known hypersensitivity to recombinant proteins, or any excipient contained in the study drug formulations.
Drug: Zimberelimab, Drug: Domvanalimab
Liver Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma, Liver, Other Digestive Organ, Hepatobiliary Cancer
UT Southwestern; Parkland Health & Hospital System
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CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (CaMMouflage)

This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Larry Anderson
102991
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05722418
STU-2023-0172
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Inclusion Criteria:

• Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
• Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination.
• Eastern Cooperative Oncology Group performance status grade of 0 or 1.
• Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
Exclusion Criteria:

• Prior treatment with CAR-T cell therapy directed at any target.
• Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
• Allogeneic stem cell transplant within 6 months before lymphodepletion.
• Known active or prior history of CNS involvement.
• Stroke or seizure within 6 months of signing ICF.
• Seropositive for or history of human immunodeficiency virus.
• Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
• Hepatitis B infection.
• Hepatitis C infection.
• Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
Biological: CB-011
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
CaMMouflage, Allogeneic, Multiple Myeloma, Relapse Refractory Multiple Myeloma, CAR-T Cells, BCMA, Cell Therapy, Cellular Immuno-therapy, CB11A, CB-011, CB-011A, CAR-T, Anti BCMA, ALLO CAR T
UT Southwestern
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Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)

Call 214-648-5005
studyfinder@utsouthwestern.edu, Sofia.Alcasey@UTSouthwestern.edu

Madhukar Trivedi
17410
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05711940
STU-2023-0052
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Inclusion Criteria:

• Aged ≥18 years at Screening
• Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5])
• If the current major depressive episode is the participant's first lifetime episode of depression, the length of the current episode must be ≥3 months and ≤2 years at Screening
• MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression
• TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode as determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and using the supplementary advice on additional antidepressants not included in MGH-ATRQ
• At Screening, agreement to discontinue all prohibited medications Key
Exclusion Criteria:

• Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder as assessed by a structured clinical interview (MINI 7.0.2)
• Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement
• Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module
• Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa as assessed by medical history and a structured clinical interview (MINI
• 0.2)
• Psychiatric inpatient within the past 12 months prior to Screening
• Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode
• Transcranial magnetic stimulation within the past six months prior to Screening
• Current enrolment in a psychological therapy programme that will not remain stable for the duration of the study. Psychological therapies cannot have been initiated within 30 days prior to Screening
• Exposure to COMP360 psilocybin therapy prior to Screening
Drug: Psilocybin
Treatment Resistant Depression
psilocybin
UT Southwestern
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A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (BOLSTER)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in patients with previously untreated cholangiocarcinoma or those that have progressed after first-line treatment for cholangiocarcinoma. The main questions it aims to answer are: - is the new drug plus standard treatment safe and tolerable - is the new drug plus standard treatment more effective than standard treatment

Call 833-722-6237
canceranswerline@utsouthwestern.edu

David Hsieh
171069
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05712356
STU-2023-0740
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Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy ≥ 3 months
• At least one measurable lesion as assessed by RECIST 1.1
• Adequate organ and marrow function
• Adequate contraception
• Patients with either of the following:
• Pathologically confirmed metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma (GBC), with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization). Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible.
• Pathologically confirmed metastatic or unresectable cholangiocarcinoma or GBC with progression of disease after first-line chemotherapy and immunotherapy.
Exclusion Criteria:

• Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
• Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment
• Active infection (viral, fungal, or bacterial) requiring systemic therapy
• Known active hepatitis B virus, hepatitis C virus, or HIV infection
• Active tuberculosis as defined per local guidance
• History of allogeneic tissue/solid organ transplant
• Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
• Pregnant or breastfeeding
• Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization
• History or clinical evidence of symptomatic central nervous system (CNS) metastases
• For first-line cholangiocarcinoma, active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent. Patients with Type 1 diabetes, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
Drug: LSTA1, Drug: Durvalumab, Drug: Cisplatin, Drug: Gemcitabine, Drug: FOLFOX regimen, Drug: Placebo
Cholangiocarcinoma, Gallbladder Cancer, Intrahepatic Cholangiocarcinoma, Bile Duct Cancer, Gallbladder Carcinoma, Esophagus, Lip, Oral Cavity and Pharynx, Other Digestive Organ, Extrahepatic Cholangiocarcinoma, Gall Bladder Cancer, Gall Bladder Carcinoma
immunotherapy, chemo, chemotherapy, first line, second line, progression
UT Southwestern
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A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer

This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.

Call 833-722-6237
canceranswerline@utsouthwestern.edu

Yair Lotan
59883
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05710848
STU-2022-1032
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Inclusion Criteria:

• Are aged 18 years or older;
• Have a history of pathologically confirmed high-grade Ta or T1 NMIBC without CIS who have completed SOC previously, with recurrent papillary disease seen on cystoscopy, and who are undergoing TURBT without perioperative intravesical chemotherapy;
• Are considered high risk for recurrence;
• Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;
• Have adequate organ and marrow function as defined below:
• Hemoglobin 9.0 g/dL;
• Absolute neutrophil count 1.5 × 109/L (1500 per mm3);
• Platelet count 75 × 109/L (75,000 per mm3);
• Serum bilirubin 1.5 × institutional upper limit of normal (ULN);
• AST (serum glutamic-oxaloacetic transaminase)/ALT (serum glutamic-pyruvic transaminase) 2.5 × institutional ULN; and
• Creatinine CL 60 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine CL: Males: Creatinine CL (mL/min) = Weight (kg) × (140 - Age)/72 × serum creatinine (mg/dL); or Females: Creatinine CL (mL/min) = Weight (kg) × (140 - Age) × 0.85/72 × serum creatinine (mg/dL).
Exclusion Criteria:

• Have a history of CIS or MIBC;
• Are receiving any other investigational agents;
• Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to resiquimod (R848), or excipients used in STM-416 including poloxamer 407 and sodium hyaluronate;
• Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Urinary tract infections are not exclusionary unless they are NCI-CTCAE Grade 3 or higher;
• Are a woman of childbearing potential regardless of contraceptive use; Note: Women of childbearing potential are only to be excluded in Phase 1 and Phase 2a to avoid bias due to the low prevalence of NMIBC in this population. However, they will be included in subsequent Phase 2/3 studies.
Drug: STM-416
Urinary Bladder, Non-muscle-invasive Bladder Cancer
Open-label, Dose escalation, STM-416, Resiquimod, Toll-like receptor 7/8, Non-Muscle Invasive Bladder Cancer, TURBT, Immunotherapy, BCG
UT Southwestern
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