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Pilot Study of Casdatifan-Treated Refractory Renal Cell Carcinoma

NCT07748988 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-08-06

No results posted yet for this study

Summary

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. The study will assess changes in HIF2-regulated gene expression through RNA sequencing of serial tumor biopsies obtained at baseline, during treatment, and at progression. Blood samples will also be collected for future analyses.

Conditions

  • Refractory Renal Cell Carcinoma

Interventions

DRUG

casdatifan

Casdatifan will be taken orally at a fixed dose of 100 mg once daily, with or without food, on a continuous schedule beginning on Cycle 1, Day 1.

Sponsors & Collaborators

  • Arcus Biosciences, Inc.

    collaborator INDUSTRY

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Brian Rini · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2029-07-01
Primary Completion
2030-07-01
Completion
2031-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07748988 on ClinicalTrials.gov