CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
A PHASE 1/1b MULTICENTER STUDY TO EVALUATE THE HUMANIZED ANTI-CD73 ANTIBODY, CPI-006, AS A SINGLE AGENT OR IN COMBINATION WITH CIFORADENANT, WITH PEMBROLIZUMAB, AND WITH CIFORADENANT PLUS PEMBROLIZUMAB IN ADULT SUBJECTS WITH ADVANCED CANCERS
1 other identifier
interventional
117
2 countries
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 nonsmall-cell-lung-cancer
Started Apr 2018
Typical duration for phase_1 nonsmall-cell-lung-cancer
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2018
CompletedFirst Posted
Study publicly available on registry
March 6, 2018
CompletedStudy Start
First participant enrolled
April 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2023
CompletedDecember 21, 2023
December 1, 2023
4.7 years
February 5, 2018
December 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Area under the curve (AUC) of CPI-006
Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Maximum serum concentration (Cmax) 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
Study Arms (6)
Cohort 1a
EXPERIMENTALCPI-006
Cohort1b
EXPERIMENTALCPI-006 + ciforadenant
Cohort 1c
EXPERIMENTALCPI-006 + pembrolizumab
Cohort 2a
EXPERIMENTALCPI-006
Cohort 2b
EXPERIMENTALCPI-006 + ciforadenant
Cohort 2c
EXPERIMENTALCPI-006 + pembrolizumab
Interventions
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression.
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression.
Subjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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
Related Publications (1)
Miller RA, Luke JJ, Hu S, Mahabhashyam S, Jones WB, Marron T, Merchan JR, Hughes BGM, Willingham SB. Anti-CD73 antibody activates human B cells, enhances humoral responses and induces redistribution of B cells in patients with cancer. J Immunother Cancer. 2022 Dec;10(12):e005802. doi: 10.1136/jitc-2022-005802.
PMID: 36600561DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
S Mahabhashyam, MD
Corvus Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2018
First Posted
March 6, 2018
Study Start
April 25, 2018
Primary Completion
December 28, 2022
Study Completion
February 19, 2023
Last Updated
December 21, 2023
Record last verified: 2023-12