CompletedPhase 1NCT03454451

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

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.

Checked against the public recordLast updated Dec 21, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations27
SponsorCorvus Pharmaceuticals, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Corvus Pharmaceuticals, Inc.
Interventions being studied
Drug: CPI-006; Drug: CPI-006 + ciforadenant; Drug: CPI-006 + pembrolizumab; Drug: CPI-006; Drug: CPI-006 + ciforadenant; Drug: CPI-006 + pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 2. 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. 3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1). 4. 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. 5. Willingness to provide tumor biopsies. Exclusion Criteria 1. History of severe hypersensitivity reaction to monoclonal antibodies. 2. 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. 3. History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis. 4. The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited. 5. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Arizona OncologyTucson, Arizona
  • City Of HopeDuarte, California
  • UC San FranciscoSan Francisco, California
  • Yale School of MedicineNew Haven, Connecticut
  • University of MiamiMiami, Florida
  • Northwestern UniversityChicago, Illinois
  • The University of ChicagoChicago, Illinois
  • The John Hopkins UniversityBaltimore, Maryland
  • Dana FarberBoston, Massachusetts
  • Comprehensive Cancer Centers of NevadaLas Vegas, Nevada
  • NY HematologyAlbany, New York
  • Roswell Park Cancer InstituteBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 21, 2023. Always confirm current availability with the study team.

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