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

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Corvus Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Metastatic Castration Resistant Prostate Cancer
Renal Cell Cancer

Treatments

Drug: Ciforadenant
Drug: Ciforadenant + atezolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02655822
CPI-444-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

502 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

502 participants in 5 patient groups

Cohort 1 - Closed
Experimental group
Description:
Ciforadenant
Treatment:
Drug: Ciforadenant
Cohort 2 - Closed
Experimental group
Description:
Ciforadenant
Treatment:
Drug: Ciforadenant
Cohort 3 - Closed
Experimental group
Description:
Ciforadenant
Treatment:
Drug: Ciforadenant
Cohort 4
Experimental group
Description:
Ciforadenant + atezolizumab
Treatment:
Drug: Ciforadenant + atezolizumab
Cohort 5 - Closed
Experimental group
Description:
Ciforadenant
Treatment:
Drug: Ciforadenant

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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