Breast Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

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).
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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

378

Study ID:

NCT03454451

Recruitment Status:

Active, not recruiting

Sponsor:

Corvus Pharmaceuticals, Inc.

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There are 26 Locations for this study

See Locations Near You

Arizona Oncology
Tucson Arizona, 85711, United States
City Of Hope
Duarte California, 91010, United States
UC San Francisco
San Francisco California, 94143, United States
Yale School of Medicine
New Haven Connecticut, 06519, United States
University of Miami
Miami Florida, 33136, United States
Northwestern University
Chicago Illinois, 60611, United States
The University of Chicago
Chicago Illinois, 60637, United States
The John Hopkins University
Baltimore Maryland, 21224, United States
Dana Farber
Boston Massachusetts, 02215, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
NY Hematology
Albany New York, 12206, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Carolina BioOncology Institute
Huntsville North Carolina, 28078, United States
Oncology Hematology Care
Cincinnati Ohio, 45242, United States
University of Oklahoma - Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
UPMC Hillman
Pittsburgh Pennsylvania, 15232, United States
Greenville
Greenville South Carolina, 29605, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States
Virginia Cancer
Fairfax Virginia, 22031, United States
Froedtert Hospital & Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Lifehouse
Camperdown New South Wales, 2050, Australia
St. Vincent's Hospital
Darlinghurst New South Wales, 2010, Australia
Westmead
Westmead New South Wales, 3168, Australia
Royal Brisbane
Herston Queensland, 4029, Australia
Monash Hospital
Clayton Victoria, 3168, Australia

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

378

Study ID:

NCT03454451

Recruitment Status:

Active, not recruiting

Sponsor:


Corvus Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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