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Brief Title: Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers

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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

INTRODUCTION

  • Org Study ID: CPI-444-001
  • Secondary ID: N/A
  • NCT ID: NCT02655822
  • Sponsor: Corvus Pharmaceuticals, Inc.

BRIEF SUMMARY

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.

  • Overall Status
    Completed
  • Start Date
    January, 2016
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab

Primary Outcome 1 - Timeframe: 28 days following first administration of ciforadenant

Primary Outcome 2 - Measure: Objective response rate per RECIST v1.1 criteria of ciforadenant as a single agent and in combination with atezolizumab

Primary Outcome 2 - Timeframe: From start of treatment to end of treatment

Primary Outcome 3 - Measure: Incidence of treatment-emergent adverse events

Primary Outcome 3 - Timeframe: up to 72 months

Primary Outcome 4 - Measure: as assessed by NCI CTCAE v.4.03

Primary Outcome 4 - Timeframe: Continuously

Primary Outcome 5 - Measure: of ciforadenant as a single agent and in combination with atezolizumab

Primary Outcome 5 - Timeframe: up to 72 months

Primary Outcome 6 - Measure: Mean and median Area under the curve (AUC) of ciforadenant

Primary Outcome 6 - Timeframe: Up to 12 months

Primary Outcome 7 - Measure: Mean and median Maximum concentration (Cmax) of ciforadenant

Primary Outcome 7 - Timeframe: Up to 12 months

Primary Outcome 8 - Measure: Identify the MDL (maximum dose level) of single agent ciforadenant

Primary Outcome 8 - Timeframe: From start of treatment to end of treatment

CONDITION

  • Renal Cell Cancer
  • Metastatic Castration Resistant Prostate Cancer

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Mehrdad Mobasher, MD, MPH

Role: Study Director

Affiliation: Corvus Pharmaceuticals

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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