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Closed (no longer recruiting)Last updated: 24 January 2024

CT832: This phase I trial is evaluating a new drug (CPI-444) alone and in combination with atezolizumab in patients with advanced cancersA Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of CPI-444 as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers

Clinical summary

Summary

This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, 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 CPI-444 as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.

Conditions

This trial is treating patients with Non Small Cell Lung Cancer, Melanoma, Renal Cell Cancer, Kidney Cancer, Breast Cancer, Colorectal Cancer, Bladder Cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

CT832

More information

Trial Identifiers

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Trial sponsor

Corvus Pharmaceuticals, Inc

Scientific Title

A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of CPI-444 as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers

Eligibility

Inclusion

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.

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.

Exclusion

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 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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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