Title

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

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    atezolizumab cpi-444 ...
  • Study Participants

    502
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.
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.
Study Started
Jan 31
2016
Primary Completion
Jun 30
2021
Study Completion
Jul 31
2021
Last Update
Aug 30
2021

Drug Ciforadenant + atezolizumab

Ciforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.

Drug Ciforadenant

100 mg orally twice daily for the first 14 days of each 28-day cycle.

Drug Ciforadenant

100 mg orally twice daily for 28 days of each 28-day cycle.

Drug Ciforadenant

200 mg orally once daily for the first 14 days of each 28-day cycle.

Drug Ciforadenant

Start with 150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.

Cohort 1 - Closed Experimental

Ciforadenant

Cohort 2 - Closed Experimental

Ciforadenant

Cohort 3 - Closed Experimental

Ciforadenant

Cohort 4 Experimental

Ciforadenant + atezolizumab

Cohort 5 - Closed Experimental

Ciforadenant

Criteria

Renal Cell Carcinoma 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.

Renal Cell Carcinoma 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.

Metastatic Castration-Resistant Prostate Cancer Inclusion Criteria

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.

Metastatic Castration-Resistant Prostate Cancer Exclusion Criteria

Has pure small-cell histology and variants with predominant (≥ 50%) neuroendocrine differentiation.
Has a 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.
No Results Posted