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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official 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

Details

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, an intravenous PD-L1 inhibitor. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.

Keywords

Non-Small Cell Lung Cancer Malignant Melanoma Renal Cell Cancer Triple Negative Breast Cancer Colorectal Cancer Bladder Cancer Metastatic Castration Resistant Prostate Cancer NSCLC MEL RCC TNBC Triple Negative Breast Neoplasms Neoplasms CRC Lung Cancer Kidney Cancer Colon Cancer Rectal Cancer Skin Cancer Breast Cancer mCRPC Prostate Cancer Prostatic Neoplasms Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Urinary Bladder Neoplasms Carcinoma, Renal Cell Melanoma Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  2. Documented incurable cancer with one of the following histologies: non-small cell lung cancer, malignant melanoma, renal cell cancer, triple negative breast cancer,colorectal cancer with microsatellite instability (MSI), bladder cancer, and metastatic castration resistant prostate cancer.
  3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  4. At least 1 but not more than 5 prior systemic therapies for advanced/recurrent or progressing disease.

You CAN'T join if...

  1. History of severe hypersensitivity reaction to monoclonal antibodies.
  2. Any active autoimmune disease or a documented history of serious autoimmune disease within the past 5 years requiring immunosuppressive therapy.
  3. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or clinical symptoms of active pneumonitis.
  4. The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
  5. If a patient is currently receiving denosumab, this must be discontinued prior to enrollment. Substitution with biphosphonates are acceptable.

Locations

  • University of California - San Francisco accepting new patients
    San Francisco, California, 94143, United States
  • Stanford Cancer Institute accepting new patients
    Stanford, California, 94305, United States
  • UCLA Medical Center accepting new patients
    Los Angeles, California, 90095, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Corvus Pharmaceuticals, Inc.
ID
NCT02655822
Phase
Phase 1
Lead Scientist
Lawrence Fong
Study Type
Interventional
Last Updated
July 18, 2017
I’m interested in this study!