Tests casdatifan alone and with other drugs in kidney cancer
Tests casdatifan, alone or combined, in adults with clear cell kidney cancer.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
Key facts
- Where
- Atlanta, Baltimore, Birmingham, Boston, Cleveland, Detroit, Louisville, Miami, Nashville, New Orleans, New York, Omaha, Pittsburgh, San Antonio, San Diego, and Santa Monica, United StatesSee the 16 sites
- Phase
- Phase 1
Where in United States
- AtlantaAtlanta, United StatesTaking people
- BaltimoreBaltimore, United StatesTaking people
- BirminghamBirmingham, United StatesTaking people
- BostonBoston, United StatesTaking people
- ClevelandCleveland, United StatesTaking people
- DetroitDetroit, United StatesTaking people
- LouisvilleLouisville, United StatesTaking people
- MiamiMiami, United StatesTaking people
- NashvilleNashville, United StatesTaking people
- New OrleansNew Orleans, United StatesTaking people
- New YorkNew York, United StatesTaking people
- OmahaOmaha, United StatesTaking people
- PittsburghPittsburgh, United StatesTaking people
- San AntonioSan Antonio, United StatesTaking people
- San DiegoSan Diego, United StatesTaking people
- Santa MonicaSanta Monica, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Arcus Biosciences, Inc.
- Trial code
- NCT05536141EU 2024-519142-70-00
- Record updated
- 2 November 2026
- Original description
The purpose of this study is to evaluate the safety and tolerability of:Read full original descriptionShow less
A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell 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 cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.
Inclusion: 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.
Exclusion: 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 investigational product hazardous; 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 and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present; 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.