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Casdatifan for the Treatment of Refractory Metastatic Clear Cell Renal Cell Carcinoma

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase changed: Early Phase 1 → Phase 1 Recruitment opened · Start date changed from estimate of Jul 1, 2029 to Sep 21, 2026 · Eligibility criteria expanded, about 30 words · 4 more Show 7 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Jul 1, 2029 to Sep 21, 2026
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 28 words
    • Site details revised
    • Study title expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a single-institution, pilot study of oral casdatifan, a selective HIF-2α inhibitor, in patients with metastatic clear cell renal cell carcinoma refractory to prior IO- and VEGF-based therapies. This phase I trial evaluates the effects of casdatifan on certain genes linked to kidney cancer growth and tests it for the treatment of clear cell renal cell cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). Casdatifan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Details
NCT Number NCT07748988
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: Arcus Biosciences, Inc.
Conditions Refractory Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov