CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
- Conditions
- Cervical CancerOvarian CancerNon-Small Cell Lung CancerColorectal CancerSarcomaRenal Cell CancerBladder CancerTriple Negative Breast CancerPancreatic CancerEndometrial Cancer
- Interventions
- Registration Number
- NCT03454451
- Lead Sponsor
- Corvus Pharmaceuticals, Inc.
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1a CPI-006 CPI-006 Cohort1b CPI-006 + ciforadenant CPI-006 + ciforadenant Cohort 2b CPI-006 + ciforadenant CPI-006 + ciforadenant Cohort 2c CPI-006 + pembrolizumab CPI-006 + pembrolizumab Cohort 1c CPI-006 + pembrolizumab CPI-006 + pembrolizumab Cohort 2a CPI-006 CPI-006
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab. From start of treatment to end of treatment, up to 36 months Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab. From start of treatment to end of treatment, up to 36 months Identify the MDL(maximum dose level) of single agent CPI-006 From start of treatment to end of treatment, up to 36 months
- Secondary Outcome Measures
Name Time Method Area under the curve (AUC) of CPI-006 Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). Objective response rate per RECIST v.1.1 criteria of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab. From start of treatment to end of treatment, up to 36 months Maximum serum concentration (Cmax) of CPI-006 Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Trial Locations
- Locations (27)
The John Hopkins University
🇺🇸Baltimore, Maryland, United States
Lifehouse
🇦🇺Camperdown, New South Wales, Australia
NY Hematology
🇺🇸Albany, New York, United States
Royal Brisbane
🇦🇺Herston, Queensland, Australia
UPMC Hillman
🇺🇸Pittsburgh, Pennsylvania, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Miami
🇺🇸Miami, Florida, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Carolina BioOncology Institute
🇺🇸Huntsville, North Carolina, United States
Arizona Oncology
🇺🇸Tucson, Arizona, United States
City Of Hope
🇺🇸Duarte, California, United States
Dana Farber
🇺🇸Boston, Massachusetts, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Greenville
🇺🇸Greenville, South Carolina, United States
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Virginia Cancer
🇺🇸Fairfax, Virginia, United States
St. Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Westmead
🇦🇺Westmead, New South Wales, Australia
Monash Hospital
🇦🇺Clayton, Victoria, Australia
The University of Chicago
🇺🇸Chicago, Illinois, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Froedtert Hospital & Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
UC San Francisco
🇺🇸San Francisco, California, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
University of Oklahoma - Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States