Brief Title
CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
Official Title
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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.
Secondary Outcome
Area under the curve (AUC) of CPI-006
Condition
Non-Small Cell Lung Cancer
Intervention
CPI-006
Study Arms / Comparison Groups
Cohort 1a
Description: CPI-006
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
378
Start Date
April 25, 2018
Completion Date
December 2023
Primary Completion Date
March 2022
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
S Mahabhashyam, MD, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT03454451
Organization ID
CPI-006-001
Responsible Party
Sponsor
Study Sponsor
Corvus Pharmaceuticals, Inc.
Study Sponsor
S Mahabhashyam, MD, Study Chair, Corvus Pharmaceuticals
Verification Date
February 2020