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

December 19, 2023 updated by: Corvus Pharmaceuticals, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Lifehouse
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital
      • Westmead, New South Wales, Australia, 3168
        • Westmead
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • San Francisco, California, United States, 94143
        • UC San Francisco
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale School of Medicine
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • The University Of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • The John Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Albany, New York, United States, 12206
        • NY Hematology
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • North Carolina
      • Huntsville, North Carolina, United States, 28078
        • Carolina BioOncology Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma - Stephenson Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital & Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1a
CPI-006
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.
Drug: CPI-006
Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.
Experimental: Cohort1b
CPI-006 + ciforadenant
Drug: 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.
Drug: 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.
Experimental: Cohort 1c
CPI-006 + pembrolizumab
Drug: 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.
Drug: CPI-006 + pembrolizumab
Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.
Experimental: Cohort 2a
CPI-006
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.
Drug: CPI-006
Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.
Experimental: Cohort 2b
CPI-006 + ciforadenant
Drug: 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.
Drug: 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.
Experimental: Cohort 2c
CPI-006 + pembrolizumab
Drug: 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.
Drug: CPI-006 + pembrolizumab
Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.
Time Frame: From start of treatment to end of treatment, up to 36 months
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.
Time Frame: From start of treatment to end of treatment, up to 36 months
From start of treatment to end of treatment, up to 36 months
Identify the MDL(maximum dose level) of single agent CPI-006
Time Frame: From start of treatment to end of treatment, up to 36 months
From start of treatment to end of treatment, up to 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the curve (AUC) of CPI-006
Time Frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
Maximum serum concentration (Cmax) of CPI-006
Time Frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
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.
Time Frame: From start of treatment to end of treatment, up to 36 months
From start of treatment to end of treatment, up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corvus Pharmaceuticals, Inc.

Investigators

  • Study Chair: S Mahabhashyam, MD, Corvus Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2018

Primary Completion (Actual)

December 28, 2022

Study Completion (Actual)

February 19, 2023

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPI-006-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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