Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing casdatifan for Clear Cell Renal Cell Carcinoma

This study wants to measure the whether it is safe and how hard side effects are to live with 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 this drug alone and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.

Official registry: https://clinicaltrials.gov/study/NCT05536141 · Arcus Biosciences, Inc. · enrollment listed as 362

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are casdatifan, Cabozantinib, or Zimberelimab. The registry lists allocation as randomized. This study wants to measure the whether it is safe and how hard side effects are to live with 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 this drug alone and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.

They plan to enroll about 362 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: casdatifan, Cabozantinib, Zimberelimab, Ipilimumab

Primary outcome (registry wording): Number of participants with dose limiting toxicities (DLTs)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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

Public study contact (from the registry)

Medical Director

+1-510-462-3330

ClinicalTrialInquiry@arcusbio.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

21 listed

+ 5 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05536141 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05536141?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05536141?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary