CPI-006 Alone and in Combination With CPI-444 and With Pembrolizumab for Patients With Advanced Cancers

Status: Active

Description

This is a phase 1 / 1b open label, multicenter, dose-selection study of CPI-006, a Type 2 humanized IgG1 antibody inhibiting enzymatic activity of CD73 and adenosine production. This trial will study the safety, tolerability, and anti-tumor activity of CPI-006 as a single agent, in combination with CPI-444, a small molecule targeting the adenosine-A2A receptor on immune cells, and in combination with pembrolizumab, an anti-PD1 antibody against various solid tumors and Non-Hodgkin lymphoma.

Eligibility Criteria

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  • Documented incurable cancer with one of the following histologies: nonsmall cell lung cancer, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability(MSI), bladder cancer, cervical cancer, uterine cancer, sarcoma, endometrial cancer, and metastatic castration resistant prostate cancer.
  • At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease.
  • Willingness to provide tumor biopsies.

Exclusion Criteria

  • History of severe hypersensitivity reaction to monoclonal antibodies.
  • Subjects who have received prior therapy with regimens containing cytotoxicT-lymphocyte antigen-4 (CTLA-4), programmed cell death ligand 1 (PDL1), or PD1 antagonists are NOT permitted to enroll unless all adverse events (AEs) while receiving prior immunotherapy have resolved to Grade 1 or baseline prior to screening.
  • History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.
  • The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
San Francisco
UCSF Medical Center-Mount Zion
Status: Approved
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available

Trial Objectives and Outline

This is a phase 1/1b open label, multicenter, dose-selection study of CPI-006, a Type 2 humanized IgG1 antibody inhibiting enzymatic activity of CD73 and adenosine production. This trial will study the safety, tolerability, and anti-tumor activity of CPI-006 as a single agent, in combination with CPI-444, a small molecule targeting the adenosine-A2A receptor on immune cells, and in combination with pembrolizumab, an anti-PD1 antibody against various solid tumors and Non-Hodgkin lymphoma. This trial is composed of dose escalation and dose expansion cohorts.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Corvus Pharmaceuticals, Inc.

Trial IDs

Primary ID CPI-006-001
Secondary IDs NCI-2018-02296
Clinicaltrials.gov ID NCT03454451