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RECRUITING
NCT05536141
PHASE1

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

Sponsor: Arcus Biosciences, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

362

Start Date

2022-10-26

Completion Date

2029-03

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

DRUG

casdatifan

Administered as specified in the treatment arm

DRUG

Cabozantinib

Administered as specified in the treatment arm

DRUG

Zimberelimab

Administered as specified in the treatment arm

DRUG

Ipilimumab

Administered as specified in the treatment arm

Locations (25)

Research Site

Birmingham, Alabama, United States

Research Site

San Diego, California, United States

Research Site

Santa Monica, California, United States

Research Site

Miami, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Louisville, Kentucky, United States

Research Site

New Orleans, Louisiana, United States

Research Site

Baltimore, Maryland, United States

Research Site

Boston, Massachusetts, United States

Research Site

Detroit, Michigan, United States

Research Site

Detroit, Michigan, United States

Research Site

Omaha, Nebraska, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Cleveland, Ohio, United States

Research Site

Cleveland, Ohio, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Nashville, Tennessee, United States

Research Site

Nashville, Tennessee, United States

Research Site

San Antonio, Texas, United States

Research Site

Camperdown, Australia

Research Site

Melbourne, Australia

Research Site

Sydney, Australia

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain