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

Trial Status: Active

This is a Phase 1 / 1b open-label, dose escalation and dose expansion study of CPI-006, a humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult subjects with select advanced cancers. CPI-006 will be evaluated as a single agent, in combination with ciforadenant (an oral adenosine 2A receptor antagonist), in combination with pembrolizumab (an anti-PD1 antibody), and in combination with ciforadenant and pembrolizumab.

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).
  • For Escalation: At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease. For Expansion: Subject must have progressed on, be refractory to, or intolerant to 1-3 prior systemic therapies.
  • 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.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: ACTIVE
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Corvus Pharmaceuticals, Inc.

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