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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 - Closed
Ciforadenant
  • Drug: Ciforadenant
    100 mg orally twice daily for the first 14 days of each 28-day cycle.
Experimental
Cohort 2 - Closed
Ciforadenant
  • Drug: Ciforadenant
    100 mg orally twice daily for 28 days of each 28-day cycle.
Experimental
Cohort 3 - Closed
Ciforadenant
  • Drug: Ciforadenant
    200 mg orally once daily for the first 14 days of each 28-day cycle.
Experimental
Cohort 4
Ciforadenant + atezolizumab
  • Drug: Ciforadenant + atezolizumab
    Ciforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.
Experimental
Cohort 5 - Closed
Ciforadenant
  • Drug: Ciforadenant
    Start with 150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.

More Details

Status
Completed
Sponsor
Corvus Pharmaceuticals, Inc.

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.