Status:
COMPLETED
CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
Lead Sponsor:
Corvus Pharmaceuticals, Inc.
Conditions:
Non-Small Cell Lung Cancer
Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 sele...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2023
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT03454451
Start Date
April 25 2018
End Date
February 19 2023
Last Update
December 21 2023
Active Locations (27)
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1
Arizona Oncology
Tucson, Arizona, United States, 85711
2
City Of Hope
Duarte, California, United States, 91010
3
UC San Francisco
San Francisco, California, United States, 94143
4
Yale School of Medicine
New Haven, Connecticut, United States, 06519