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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | April 25, 2018 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.
Primary Outcome 1 - Time Frame: From start of treatment to end of treatment, up to 36 months
Primary Outcome 2 - Measure: 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.
Primary Outcome 2 - Time Frame: From start of treatment to end of treatment, up to 36 months
Primary Outcome 3 - Measure: Identify the MDL(maximum dose level) of single agent CPI-006
Primary Outcome 3 - Time Frame: From start of treatment to end of treatment, up to 36 months
Criteria:
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.
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: S Mahabhashyam, MD
Role: Study Chair
Affiliation: Corvus Pharmaceuticals
Facility | Status | Contact |
---|---|---|
Arizona Oncology Associates, PC - HOPE Tucson, Arizona 85711 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
City Of Hope Duarte, California 91010 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
UCSF Medical Center San Francisco, California 94143 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
Yale School of Medicine New Haven, Connecticut 06519 United States |
Recruiting |
Site Coordinator 203-785-3482 ycci@yale.edu |
University of Miami Miami, Florida 33136 United States |
Recruiting |
Study Coordinator 305-243-0865 txl351@med.miami.edu |
Northwestern University Chicago, Illinois 60611 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
The University of Chicago Chicago, Illinois 60637 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
The John Hopkins University Baltimore, Maryland 21224 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
Dana Farber Cancer Institute Boston, Massachusetts 02215 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada 89169 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
New York Oncology Hematology, P.C. Albany, New York 12206 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
Roswell Park Cancer Institute Buffalo, New York 14263 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
Icahn School of Medicine at Mount Sinai New York, New York 10029 United States |
Recruiting |
Site Coordinator 212-824-7309 ccto@mssm.edu |
Carolina BioOncology Institute Huntsville, North Carolina 28078 United States |
Recruiting |
Study Coordinator 704-947-6599 info@carolinabiooncology.org |
Oncology Hematology Care, Inc. Cincinnati, Ohio 45242 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
University of Oklahoma - Stephenson Cancer Center Oklahoma City, Oklahoma 73104 United States |
Recruiting |
Site Coordinator 405-271-1112 SCC-Clinical-Trials-Office@ouhsc.edu |
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania 15232 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
Prisma Health Cancer Inst - Faris Greenville, South Carolina 29605 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
Sarah Cannon Research Institute Nashville, Tennessee 37203 United States |
Recruiting |
Site Coordinator 615-329-7274 asksarah@sarahcannon.com |
Mary Crowley Cancer Research Dallas, Texas 75230 United States |
Recruiting |
Study Coordinator 972-566-3000 information@marycrowley.org |
Virginia Cancer Specialists, PC Fairfax, Virginia 22031 United States |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
Froedtert Hospital & Medical College of Wisconsin Milwaukee, Wisconsin 53226 United States |
Completed | |
Chris O'Brien Lifehouse Camperdown, New South Wales 2050 Australia |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
St. Vincent's Hospital Darlinghurst, New South Wales 2010 Australia |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
Westmead Hospital Westmead, New South Wales 3168 Australia |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
Royal Brisbane and Women's Hospital Herston, Queensland 4029 Australia |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |
Monash Health Clayton, Victoria 3168 Australia |
Recruiting |
C Clark 650-900-4520 cpi006-communications@corvuspharma.com |