A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Arcus Biosciences, Inc. (industry)

Phase: 3

Start date: Sept. 8, 2025

Planned enrollment: 720

Trial ID: NCT07011719
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: casdatifan (AB521)

TrialFetch AI Analysis

Goal: Determine whether adding casdatifan to cabozantinib improves progression-free survival after progression on or after anti-PD-1 or anti-PD-L1 therapy in advanced clear cell renal cell carcinoma.

Patients: Adults with unresectable locally advanced or metastatic renal cell carcinoma with a clear cell component, measurable disease, and Karnofsky performance status of at least 80%. Prior HIF-2α inhibitor or cabozantinib treatment is excluded.

Design: Multicenter, randomized, double-blind, active-control trial comparing two oral treatment regimens.

Treatments: Patients receive casdatifan plus cabozantinib or placebo plus cabozantinib. Casdatifan is an investigational HIF-2α inhibitor that blocks HIF-2α-dependent gene transcription, a pathway commonly activated in clear cell renal cell carcinoma. In a prior single-arm study of casdatifan alone, confirmed response rates were 35% at 100 mg daily and 31% across studied expansion doses; these results do not establish the benefit of the combination. Cabozantinib is an established oral targeted therapy for advanced renal cell carcinoma and is given in both arms.

Outcomes: The primary endpoint is progression-free survival by blinded independent central review using RECIST 1.1. Secondary endpoints include overall survival, objective response rate, duration of response, disease control rate, adverse events, and time to kidney cancer symptom deterioration.

Burden on patient: Likely moderate: both regimens are oral, but patients will need clinic visits, imaging to assess response, safety monitoring, and symptom assessments. No research biopsies or intensive pharmacokinetic sampling are specified; visit and scan frequency are not provided.

Last updated: Sep 2026

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CHU Brest - Hôpital Morvan

Brest, France

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Status: Recruiting

Hopital Saint Eloi

Montpellier, France

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Institut Gustave Roussy

Villejuif, France

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Krankenhaus Nordwest GmbH

Frankfurt, Germany

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Universitaetsklinikum Halle (Saale)

Halle, Germany

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Universitaetsmedizin Rostock

Rostock, Germany

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Isala

Zwolle, Netherlands

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Radboudumc

Nijmegen, Netherlands

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Pratia MCM Krakow

Krakow, Poland

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S.C Oncomed S.R.L

Timișoara, Romania

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S.C. Sigmedical Services SRL

Suceava, Romania

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CHA Bundang Medical Center, CHA University

Seongnam, South Korea

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Severance Hospital, Yonsei University Health System

Seoul, South Korea

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Hospital Clinic de Barcelona

Barcelona, Spain

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Barts Hospital

London, United Kingdom

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Royal Devon and Exeter Hospital (Wonford)

Exeter, United Kingdom

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City of Hope - Phoenix Cancer Center

Goodyear, Arizona, 85338, United States

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Mayo Clinic - Phoenix

Phoenix, Arizona, 85054, United States

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City Of Hope National Medical Center

Duarte, California, 91010, United States

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UCLA Hematology Oncology - 100 Med Plaza

Los Angeles, California, 90095, United States

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University of California San Diego Moores Cancer Center

San Diego, California, 92103, United States

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University of California San Diego Moores Cancer Center

La Jolla, California, 92103, United States

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Yale University

New Haven, Connecticut, 06519, United States

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Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

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City of Hope Cancer Center Atlanta

Newnan, Georgia, 30265, United States

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Emory University - Atlanta

Atlanta, Georgia, 30322, United States

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Piedmont Cancer Institute OneOncology

Atlanta, Georgia, 30318, United States

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City of Hope - Chicago Cancer Center

Zion, Illinois, 60099, United States

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Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

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Norton Cancer Institute PARENT

Louisville, Kentucky, 40207, United States

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Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

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Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

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Mayo Clinic

Rochester, Minnesota, 55905, United States

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Washington University School of Medicine

St Louis, Missouri, 63110, United States

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The University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

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University of Rochester Medical Center

Rochester, New York, 14642, United States

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UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

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Cleveland Clinic Foundation

Cleveland, Ohio, 44106, United States

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University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

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Compass Oncology, OR

Portland, Oregon, 97212, United States

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SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

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Vanderbilt

Nashville, Tennessee, 37232, United States

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Texas Tech University Health Science Center

Lubbock, Texas, 79430, United States

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The University of Utah - Huntsman Cancer Institute (HCI)

Salt Lake City, Utah, 84112, United States

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