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A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
NCT05536141 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Ipilimumab
- DRUG Zimberelimab
- DRUG Cabozantinib
- DRUG casdatifan
Study Locations (20)
California
- University of California at San Diego — San Diego
- UCLA — Santa Monica
Michigan
- Barbara Ann Karmanos Cancer Center — Detroit
- Henry Ford Health System — Detroit
New York
- Tisch Cancer Institute, Icahn Mount Sinai Hospital — New York
- Memorial Sloan Kettering — New York
Ohio
- University Hospitals Cleveland Clinical — Cleveland
- Cleveland Clinic — Cleveland
Tennessee
- Sarah Cannon — Nashville
- Vanderbilt-Ingram Cancer Center — Nashville
Alabama
- University of Alabama at Birmingham — Birmingham
Florida
- University of Miami — Miami
Georgia
- Emory University — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2022-10-26 |
| Est. Completion | 2029-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05536141
The ClinicalTrials.gov registry entry for NCT05536141 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arcus Biosciences, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Solid Tumors appearing as the primary indexed condition, and to 4 interventions — of which Ipilimumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05536141 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Michigan, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05536141 about?
NCT05536141 is a clinical study titled "A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors". 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...
What is the current status of trial NCT05536141?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 362 participants. The study started on 2022-10-26. Estimated completion is 2029-03.
What conditions does trial NCT05536141 study?
This clinical trial studies the following conditions: Solid Tumors, Clear Cell Renal Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05536141?
The interventions under investigation include: Ipilimumab (DRUG), Zimberelimab (DRUG), Cabozantinib (DRUG), casdatifan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05536141?
This trial is sponsored by Arcus Biosciences, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05536141 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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