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NCT05536141PHASE1Recruiting

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors

Arcus Biosciences, Inc.

Start Date

10/26/2022

Completion Date

3/1/2029

Summary

The purpose of this study is to evaluate the safety and tolerability 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 monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * 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 * Creatinine clearance ≥ 40 mL/min Key Exclusion Criteria: * Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product * Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous * History of trauma or major surgery within 28 days prior to the first dose of investigational product * For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

casdatifan

DRUG

Cabozantinib

DRUG

Zimberelimab

DRUG

Ipilimumab

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Conditions

Clear Cell Renal Cell CarcinomaSolid Tumors

Locations

Research Site

Birmingham, Alabama 35294

United States

Research Site

San Diego, California 92093

United States

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Santa Monica, California 90404

United States

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Miami, Florida 33136

United States

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Atlanta, Georgia 30322-1013

United States

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Louisville, Kentucky 40202

United States

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New Orleans, Louisiana 70121

United States

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Baltimore, Maryland 21287

United States

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Boston, Massachusetts 02215

United States

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Detroit, Michigan 48201

United States

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Detroit, Michigan 48202

United States

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Omaha, Nebraska 68124

United States

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New York, New York 10029

United States

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New York, New York 10065

United States

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Cleveland, Ohio 44106

United States

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Cleveland, Ohio 44195

United States

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Pittsburgh, Pennsylvania 15232

United States

Research Site

Nashville, Tennessee 37203

United States

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Nashville, Tennessee 37240

United States

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San Antonio, Texas 78229

United States

Research Site

Camperdown,

Australia

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Melbourne,

Australia

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Sydney,

Australia

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Seoul,

South Korea

Research Site

Barcelona,

Spain