Phase 1 / 1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers

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.

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.

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