Recruiting
Phase 3

Casdatifan vs. Cabozantinib

Sponsor:

Arcus Biosciences, Inc.

Code:

NCT07011719

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Advanced Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Casdatifan

Cabozantinib

Placebo

Study Details

Brief summary:

The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Advanced Clear Cell Renal Cell Carcinoma

Study ID

NCT07011719

Start date

Sep 8, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.
  • A Karnofsky Performance Status (KPS) score ≥ 80%
  • At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.
  • Adequate organ and marrow function, ≤ 1 week prior to randomization.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.

Exclusion Criteria:

  • Received prior treatment with a HIF-2α inhibitor or cabozantinib.
  • Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
  • Ongoing clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies.
  • Uncontrolled or poorly controlled hypertension, defined as a sustained blood pressure > 150 mmHg systolic or > 90 mmHg diastolic despite optimal antihypertensive treatment.
  • History of leptomeningeal disease or spinal cord compression.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

720 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (Experimental Arm)

Casdatifan and cabozantinib taken orally

placebo comparator: Arm B (Comparator Arm)

Placebo and cabozantinib taken orally

Interventions

Casdatifan

Administered as specified in the treatment arm

Cabozantinib

Administered as specified in the treatment arm

Placebo

Administered as specified in the treatment arm

Primary outcome measure

  • Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 [ Time Frame: up to approximately 33 months ]

Central Contacts and Locations

Central contacts

Medical Director

+1-510-462-3330clinicaltrials@arcusbio.com

Locations

Research Site

Recruiting

Gilbert, Arizona, United States, 85234

Research Site

Recruiting

Goodyear, Arizona, United States, 85338

Research Site

Recruiting

Phoenix, Arizona, United States, 85054

Research Site

Recruiting

Duarte, California, United States, 91010

Research Site

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Irvine, California, United States, 91304

Research Site

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La Jolla, California, United States, 92103

Research Site

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Los Angeles, California, United States, 90095

Research Site

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Palo Alto, California, United States, 94304

Research Site

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Sacramento, California, United States, 95817

Research Site

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San Diego, California, United States, 92103

Research Site

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Aurora, Colorado, United States, 80045

Research Site

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New Haven, Connecticut, United States, 06519

Research Site

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Washington D.C., District of Columbia, United States, 20057

Research Site

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Jacksonville, Florida, United States, 32224

Research Site

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Miami, Florida, United States, 33136

Research Site

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Orlando, Florida, United States, 32804

Research Site

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Atlanta, Georgia, United States, 30318

Research Site

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Atlanta, Georgia, United States, 30322

Research Site

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Newnan, Georgia, United States, 30265

Research Site

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Zion, Illinois, United States, 60099

Research Site

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Indianapolis, Indiana, United States, 46202

Research Site

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Louisville, Kentucky, United States, 40207

Research Site

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Jefferson, Louisiana, United States, 70121

Research Site

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Baltimore, Maryland, United States, 21287

Research Site

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Boston, Massachusetts, United States, 02114

Research Site

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Boston, Massachusetts, United States, 02215

Research Site

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Rochester, Minnesota, United States, 55905

Research Site

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St Louis, Missouri, United States, 63110

Research Site

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Omaha, Nebraska, United States, 68198

Research Site

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New Brunswick, New Jersey, United States, 08903

Research Site

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Buffalo, New York, United States, 14263

Research Site

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New York, New York, United States, 10461

Research Site

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Rochester, New York, United States, 14642

Research Site

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Chapel Hill, North Carolina, United States, 27514

Research Site

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Durham, North Carolina, United States, 27710

Research Site

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Cleveland, Ohio, United States, 44106

Research Site

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Portland, Oregon, United States, 97212

Research Site

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Monroeville, Pennsylvania, United States, 15146

Research Site

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Charleston, South Carolina, United States, 29425

Research Site

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Nashville, Tennessee, United States, 37203

Research Site

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Nashville, Tennessee, United States, 37232

Research Site

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Dallas, Texas, United States, 75390

Research Site

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Lubbock, Texas, United States, 79430

Research Site

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Salt Lake City, Utah, United States, 84112

Research Site

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Charlottesville, Virginia, United States, 22903

Research Site

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Seattle, Washington, United States, 98109

Research Site

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Calgary, Canada

Research Site

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Edmonton, Canada

Research Site

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Hamilton, Canada

Research Site

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Montreal, Canada

Research Site

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Sherbrooke, Canada

Research Site

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Toronto, Canada

Research Site

Recruiting

Vancouver, Canada

More Information

Sponsor

Arcus Biosciences, Inc.

Last update posted

Sep 2, 2026

Last verified

Apr, 2026

Keywords

  • Casdatifan
  • Metastatic Clear Cell Renal Cell Carcinoma
  • Advanced Clear Cell Renal Cell Carcinoma
  • Kidney Cancer
  • PEAK-1
  • AB521
  • ccRCC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arcus Biosciences, Inc. on 2026-09-02.