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New treatment option for Clear Cell Renal Cell Carcinoma
Official title A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
ClinicalTrials.gov ID: NCT05536141
What this study is testing
What is casdatifan?
casdatifan is an investigational medicine, being studied as a potential treatment for clear cell renal cell carcinoma.
Also referred to as AB521.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and tolerability of: casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must have at least one measurable lesion per RECIST guidance
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
- Disease-specific criteria for dose escalation:
- Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
- Creatinine clearance ≥ 40 mL/min Disease-specific criteria for dose-expansion:
You likely can't join if
- Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
- Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's...
- History of trauma or major surgery within 28 days prior to the first dose of investigational product
- For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Note: Other protocol...
See the full eligibility criteria
- Must have at least one measurable lesion per RECIST guidance
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1
- Disease-specific criteria for dose escalation:
- Participants may have any pathologically confirmed solid tumor type where no other treatment options are available
- Creatinine clearance ≥ 40 mL/min Disease-specific criteria for dose-expansion:
- Histologically confirmed ccRCC
- Creatinine clearance ≥ 40 mL/min Key
- Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product
- Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of...
- History of trauma or major surgery within 28 days prior to the first dose of investigational product
- For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- San Diego, California, United States
- Santa Monica, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Camperdown, Australia
- Melbourne, Australia
- Sydney, Australia
- Seoul, South Korea
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; San Diego, California, United States; Santa Monica, California, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Louisville, Kentucky, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.