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
Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 in participants with ccRCC in the dose expansion stage
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
University of California at San Diego
NOT_YET_RECRUITING
San Diego
UCLA
RECRUITING
Santa Monica
Florida
University of Miami
RECRUITING
Miami
Georgia
Emory University
RECRUITING
Atlanta
Kentucky
University of Louisville Brown Cancer Center
RECRUITING
Louisville
Louisiana
Oschner Health
RECRUITING
New Orleans
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Michigan
Barbara Ann Karmanos Cancer Center
RECRUITING
Detroit
Henry Ford Health System
RECRUITING
Detroit
Nebraska
Nebraska Cancer Specialists - Oncology Hematology West PC
RECRUITING
Omaha
New York
Tisch Cancer Institute, Icahn Mount Sinai Hospital
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
University Hospitals Cleveland Clinical
RECRUITING
Cleveland
Pennsylvania
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
Sarah Cannon
RECRUITING
Nashville
Vanderbilt-Ingram Cancer Center
RECRUITING
Nashville
Texas
South Texas Accelerated Research Therapeutics, LLC
RECRUITING
San Antonio
Washington
Medical Oncology Associates Summit Cancer Centers
NOT_YET_RECRUITING
Spokane
Other Locations
Australia
Chris O'Brien Lifehouse
NOT_YET_RECRUITING
Camperdown
Box Hill Hospital
NOT_YET_RECRUITING
Melbourne
Ashford Cancer Centre Research/ICON
RECRUITING
Sydney
Macquarie University Hospital
NOT_YET_RECRUITING
Sydney
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Bundang Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Medical Director
ClinicalTrialInquiry@arcusbio.com
+1-510-462-3330
Time Frame
Start Date: 2022-10-26
Estimated Completion Date: 2027-07
Participants
Target number of participants: 302
Treatments
Experimental: Dose Escalation Cohort 1
Participants will receive casdatifan orally once daily
Experimental: Dose Escalation Cohort 2
Participants will receive casdatifan orally once daily
Experimental: Dose Escalation Cohort 3
Participants will receive casdatifan orally twice daily
Experimental: Dose Escalation Cohort 4
Participants will receive casdatifan orally once daily
Experimental: Dose Escalation Cohort 5
Participants will receive casdatifan orally once daily
Experimental: Dose Expansion Cohort 1
Participants will receive casdatifan orally
Experimental: Dose Expansion Cohort 2
Participants will receive casdatifan orally
Experimental: Dose Expansion Cohort 3
Participants will receive casdatifan orally
Experimental: Dose Expansion Cohort 4
Participants will receive casdatifan orally with with cabozantinib orally
Experimental: Dose Expansion Cohort 5
Participants will receive casdatifan orally
Experimental: Dose Expansion Cohort 6
Participants will receive casdatifan orally
Experimental: Dose Expansion Cohort 7
Participants will receive casdatifan orally with zimberelimab infusion
Experimental: Dose Expansion Cohort 8
Participants will receive casdatifan orally
Related Therapeutic Areas
Sponsors
Leads: Arcus Biosciences, Inc.