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

NCT02655822

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, 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.

Related Conditions:
  • Prostate Carcinoma
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CPI-444-001
  • NCT ID: NCT02655822

Conditions

  • Renal Cell Cancer
  • Metastatic Castration Resistant Prostate Cancer

Interventions

DrugSynonymsArms
CiforadenantCohort 1 - Closed
CiforadenantCohort 2 - Closed
CiforadenantCohort 3 - Closed
Ciforadenant + atezolizumabCohort 4
CiforadenantCohort 5 - Closed

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1 - ClosedExperimentalCiforadenant
  • Ciforadenant
Cohort 2 - ClosedExperimentalCiforadenant
  • Ciforadenant
Cohort 3 - ClosedExperimentalCiforadenant
  • Ciforadenant
Cohort 4ExperimentalCiforadenant + atezolizumab
  • Ciforadenant + atezolizumab
Cohort 5 - ClosedExperimentalCiforadenant
  • Ciforadenant

Eligibility Criteria

        Renal Cell Carcinoma Inclusion Criteria

          1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

          2. Documented pathologic diagnosis of clear cell RCC.

          3. Relapsed or refractory to 1-2 prior lines of therapy containing at least an
             anti-PD-(L)1 agent.

          4. Measurable disease according to RECIST v1.1

          5. Mandatory newly collected tumor biopsy sample obtained prior to treatment initiation.

        Renal Cell Carcinoma Exclusion Criteria

          1. History of severe hypersensitivity reaction to monoclonal antibodies.

          2. 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.

          3. 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

          1. Documentation of disease: progressive CRPC with histologically or cytologically
             confirmed adenocarcinoma of the prostate.

          2. 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

          3. 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).

          4. Mandatory newly collected tumor biopsy sample obtained prior to treatment initiation.

          5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

        Metastatic Castration-Resistant Prostate Cancer Exclusion Criteria

          1. Has pure small-cell histology and variants with predominant (≥ 50%) neuroendocrine
             differentiation.

          2. Has a history of severe hypersensitivity reaction to monoclonal antibodies.

          3. 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.

          4. Has an active autoimmune disease requiring systemic treatment with in the past 2 years
             OR a documented history of clinically severe autoimmune disease.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab
Time Frame:28 days following first administration of ciforadenant
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Corvus Pharmaceuticals, Inc.

Trial Keywords

  • RCC
  • Kidney Cancer
  • mCRPC
  • Prostate Cancer

Last Updated

December 11, 2020