Find Renal Cell Carcinoma (RCC) Clinical Trials Near You
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 (25) 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 or zimberelimab and ipilimumab 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
Research Site
RECRUITING
Birmingham
California
Research Site
RECRUITING
San Diego
Research Site
RECRUITING
Santa Monica
Florida
Research Site
RECRUITING
Miami
Georgia
Research Site
RECRUITING
Atlanta
Kentucky
Research Site
RECRUITING
Louisville
Louisiana
Research Site
RECRUITING
New Orleans
Massachusetts
Research Site
RECRUITING
Boston
Maryland
Research Site
RECRUITING
Baltimore
Michigan
Research Site
RECRUITING
Detroit
Research Site
RECRUITING
Detroit
Nebraska
Research Site
RECRUITING
Omaha
New York
Research Site
RECRUITING
New York
Research Site
RECRUITING
New York
Ohio
Research Site
RECRUITING
Cleveland
Research Site
RECRUITING
Cleveland
Pennsylvania
Research Site
RECRUITING
Pittsburgh
Tennessee
Research Site
RECRUITING
Nashville
Research Site
RECRUITING
Nashville
Texas
Research Site
RECRUITING
San Antonio
Other Locations
Australia
Research Site
NOT_YET_RECRUITING
Camperdown
Research Site
NOT_YET_RECRUITING
Melbourne
Research Site
RECRUITING
Sydney
Republic of Korea
Research Site
RECRUITING
Seoul
Spain
Research Site
NOT_YET_RECRUITING
Barcelona
Contact Information
Primary
Medical Director
ClinicalTrialInquiry@arcusbio.com
+1-510-462-3330
Time Frame
Start Date:2022-10-26
Estimated Completion Date:2029-03
Participants
Target number of participants:362
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
Experimental: Dose Expansion Cohort 9
Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion
Experimental: Dose Expansion Cohort 10
Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion