Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers
- Conditions
- Renal Cell CancerMetastatic Castration Resistant Prostate Cancer
- Interventions
- Registration Number
- NCT02655822
- Lead Sponsor
- Corvus Pharmaceuticals, Inc.
- Brief Summary
This is a phase 1/1b open-label, multicenter, dose-selection study of ciforadenant, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of ciforadenant as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. Ciforadenant blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.
- Detailed Description
This is a phase 1/1b open-label, multicenter, dose-selection study of ciforadenant, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of ciforadenant as a single agent and in combination with atezolizumab, an intravenous PD-L1 inhibitor. Ciforadenant blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 502
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 - Closed Ciforadenant Ciforadenant Cohort 2 - Closed Ciforadenant Ciforadenant Cohort 3 - Closed Ciforadenant Ciforadenant Cohort 4 Ciforadenant + atezolizumab Ciforadenant + atezolizumab Cohort 5 - Closed Ciforadenant Ciforadenant
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab 28 days following first administration of ciforadenant Objective response rate per RECIST v1.1 criteria of ciforadenant as a single agent and in combination with atezolizumab From start of treatment to end of treatment, up to 72 months Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.4.03, of ciforadenant as a single agent and in combination with atezolizumab Continuously, up to 72 months Identify the MDL (maximum dose level) of single agent ciforadenant From start of treatment to end of treatment, up to 72 months. Mean and median Area under the curve (AUC) of ciforadenant Up to 12 months Mean and median Maximum concentration (Cmax) of ciforadenant Up to 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
British Columbia Cancer Agency - Vancouver Centre
🇨🇦Vancouver, British Columbia, Canada
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of California - San Francisco
🇺🇸San Francisco, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Monash Health
🇦🇺Clayton, Victoria, Australia
Yale University
🇺🇸New Haven, Connecticut, United States
Stanford Cancer Institute
🇺🇸Stanford, California, United States
University of Miami Hospital and Clinics
🇺🇸Miami, Florida, United States
Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Pittsburgh Medical Center Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States