A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of Ciforadenant as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable 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.
• 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.
• Documentation of disease: progressive CRPC with histologically or cytologically confirmed adenocarcinoma of the prostate.
• Patients must have radiologically evident metastatic disease, but it can be measurable or non-measurable disease:
‣ Measurable disease: nodal, visceral, or extra nodal lesions according to RECIST v1.1 using a diagnostic computed tomography
⁃ Non-measurable disease: bone only disease (up to 1/3 of study population) per PCWG3 criteria
• 1-3 prior lines of therapy, including at least one newer generation androgen synthesis inhibitor (e.g., abiraterone) or androgen receptor antagonist (e.g., enzalutamide, apalutamide, darolutamide).
• Mandatory newly collected tumor biopsy sample obtained prior to treatment initiation.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.