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A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors
Sponsor: Arcus Biosciences, Inc.
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
2026-03-30
Healthy Volunteers
No
Interventions
casdatifan
Administered as specified in the treatment arm
Cabozantinib
Administered as specified in the treatment arm
Zimberelimab
Administered as specified in the treatment arm
Ipilimumab
Administered as specified in the treatment arm
Locations (29)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California at San Diego
San Diego, California, United States
UCLA
Santa Monica, California, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Louisville Brown Cancer Center
Louisville, Kentucky, United States
Oschner Health
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Nebraska Cancer Specialists - Oncology Hematology West PC
Omaha, Nebraska, United States
Tisch Cancer Institute, Icahn Mount Sinai Hospital
New York, New York, United States
Memorial Sloan Kettering
New York, New York, United States
University Hospitals Cleveland Clinical
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Chris O'Brien Lifehouse
Camperdown, Australia
Box Hill Hospital
Melbourne, Australia
Ashford Cancer Centre Research/ICON
Sydney, Australia
Macquarie University Hospital
Sydney, Australia
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain