CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
Completed · Phase 1
Conditions studied: Non-Small Cell Lung Cancer, Renal Cell Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Cervical Cancer, Ovarian Cancer, Pancreatic Cancer, Endometrial Cancer, Sarcoma, Squamous Cell Carcinoma of the Head and Neck, Bladder Cancer, Metastatic Castration Resistant Prostate Cancer, Non-hodgkin Lymphoma
In brief
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.
Key facts
- Study ID
- NCT03454451
- Run by
- Corvus Pharmaceuticals, Inc.
- People needed
- 117
- Starts
- 2018-04-25
- Expected to finish
- 2023-02-19
- Last updated by the study team
- 2023-12-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Arizona Oncology — Tucson, Arizona, United States
- City Of Hope — Duarte, California, United States
- UC San Francisco — San Francisco, California, United States
- Yale School of Medicine — New Haven, Connecticut, United States
- University of Miami — Miami, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- The University of Chicago — Chicago, Illinois, United States
- The John Hopkins University — Baltimore, Maryland, United States
- Dana Farber — Boston, Massachusetts, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- NY Hematology — Albany, New York, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Carolina BioOncology Institute — Huntsville, North Carolina, United States
- Oncology Hematology Care — Cincinnati, Ohio, United States
- University of Oklahoma - Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
- UPMC Hillman — Pittsburgh, Pennsylvania, United States
- Greenville — Greenville, South Carolina, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Mary Crowley Cancer Research — Dallas, Texas, United States
- Virginia Cancer — Fairfax, Virginia, United States
- Froedtert Hospital & Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Lifehouse — Camperdown, New South Wales, Australia
- St. Vincent's Hospital — Darlinghurst, New South Wales, Australia
- Westmead — Westmead, New South Wales, Australia
Full record on ClinicalTrials.gov
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