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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03454451
Other study ID # CPI-006-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 25, 2018
Est. completion date February 19, 2023

Study information

Verified date December 2023
Source Corvus Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date February 19, 2023
Est. primary completion date December 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CPI-006
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression.
CPI-006 + ciforadenant
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.
CPI-006 + pembrolizumab
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.
CPI-006
Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.
CPI-006 + ciforadenant
Selected dose of CPI-006 administered intravenously once every 21 days, in combination with CPI-444 orally twice daily until disease progression.
CPI-006 + pembrolizumab
Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.

Locations

Country Name City State
Australia Lifehouse Camperdown New South Wales
Australia Monash Hospital Clayton Victoria
Australia St. Vincent's Hospital Darlinghurst New South Wales
Australia Royal Brisbane Herston Queensland
Australia Westmead Westmead New South Wales
United States NY Hematology Albany New York
United States The John Hopkins University Baltimore Maryland
United States Dana Farber Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Northwestern University Chicago Illinois
United States The University of Chicago Chicago Illinois
United States Oncology Hematology Care Cincinnati Ohio
United States Mary Crowley Cancer Research Dallas Texas
United States City Of Hope Duarte California
United States Virginia Cancer Fairfax Virginia
United States Greenville Greenville South Carolina
United States Carolina BioOncology Institute Huntsville North Carolina
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States University of Miami Miami Florida
United States Froedtert Hospital & Medical College of Wisconsin Milwaukee Wisconsin
United States Sarah Cannon Research Institute Nashville Tennessee
United States Yale School of Medicine New Haven Connecticut
United States Icahn School of Medicine at Mount Sinai New York New York
United States University of Oklahoma - Stephenson Cancer Center Oklahoma City Oklahoma
United States UPMC Hillman Pittsburgh Pennsylvania
United States UC San Francisco San Francisco California
United States Arizona Oncology Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Corvus Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Identify the MDL(maximum dose level) of single agent CPI-006 From start of treatment to end of treatment, up to 36 months
Secondary Area under the curve (AUC) of CPI-006 Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Secondary Maximum serum concentration (Cmax) of CPI-006 Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Secondary 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
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