CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454451
• Other study ID #: CPI-006-001
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Renal Cell
• Cervical Cancer
• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Metastatic Castration Resistant Prostate Cancer
• Non-hodgkin Lymphoma
• Non-Small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Renal Cell Cancer
• Sarcoma
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

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