Phase 1 / 1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Documented pathologic diagnosis of clear cell RCC.
- Relapsed or refractory to 1-2 prior lines of therapy containing at least an anti-PD-(L)1 agent.
- Measurable disease according to RECIST v1.1
- Mandatory newly collected tumor biopsy sample obtained prior to treatment initiation.
Exclusion Criteria
- History of severe hypersensitivity reaction to monoclonal antibodies.
- Has immunodeficiency or requires treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment.
- Has an active autoimmune disease requiring systemic treatment with in the past 2 years OR a documented history of clinically severe autoimmune disease.
Arizona
Tucson
California
Los Angeles
Palo Alto
San Francisco
Colorado
Aurora
Connecticut
New Haven
District of Columbia
Washington
Florida
Miami
Georgia
Atlanta
Illinois
Chicago
Indiana
Indianapolis
Maryland
Baltimore
Massachusetts
Boston
Michigan
Detroit
Missouri
Saint Louis
Nebraska
Omaha
New York
Buffalo
New York
Ohio
Cleveland
Columbus
Pennsylvania
Pittsburgh
Texas
Dallas
Washington
Seattle
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.
Trial Phase Phase I
Trial Type Treatment
Lead Organization
Corvus Pharmaceuticals, Inc.
- Primary ID CPI-444-001
- Secondary IDs NCI-2016-00227
- Clinicaltrials.gov ID NCT02655822