SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: Study To Evaluate The Humanized Anti-CD73 Antibody, CPI-006, As A Single Agent, In Combination With CPI-444, And In Combination With Pembrolizumab In Adult Subjects 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


  • Org Study ID: CPI-006-001
  • Secondary ID:
  • NCT ID: NCT03454451
  • NCT Alias:
  • Sponsor: Corvus Pharmaceuticals, Inc. - Industry
  • Source: Corvus Pharmaceuticals, Inc.

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.

Overal Status Start Date Phase Study Type
Recruiting April 25, 2018 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.

Primary Outcome 1 - Time Frame: From start of treatment to end of treatment, up to 36 months

Primary Outcome 2 - Measure: 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.

Primary Outcome 2 - Time Frame: From start of treatment to end of treatment, up to 36 months

Primary Outcome 3 - Measure: Identify the MDL(maximum dose level) of single agent CPI-006

Primary Outcome 3 - Time Frame: From start of treatment to end of treatment, up to 36 months

Condition:

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

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.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: S Mahabhashyam, MD

Role: Study Chair

Affiliation: Corvus Pharmaceuticals

Locations

Facility Status Contact
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona 85711
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
City Of Hope
Duarte, California 91010
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
UCSF Medical Center
San Francisco, California 94143
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
Yale School of Medicine
New Haven, Connecticut 06519
United States
Recruiting Site Coordinator
203-785-3482
ycci@yale.edu
University of Miami
Miami, Florida 33136
United States
Recruiting Study Coordinator
305-243-0865
txl351@med.miami.edu
Northwestern University
Chicago, Illinois 60611
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
The University of Chicago
Chicago, Illinois 60637
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
The John Hopkins University
Baltimore, Maryland 21224
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
New York Oncology Hematology, P.C.
Albany, New York 12206
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
Roswell Park Cancer Institute
Buffalo, New York 14203
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Recruiting Site Coordinator
212-824-7309
ccto@mssm.edu
Carolina BioOncology Institute
Huntsville, North Carolina 28078
United States
Recruiting Study Coordinator
704-947-6599
info@carolinabiooncology.org
Oncology Hematology Care, Inc.
Cincinnati, Ohio 45242
United States
Recruiting Deborah Strahs
650-900-4518
dstrahs@corvuspharma.com
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Site Coordinator
405-271-1112
SCC-Clinical-Trials-Office@ouhsc.edu
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Recruiting Deborah Strahs
650-900-4518
dstrahs@corvuspharma.com
Prisma Health Cancer Inst - Faris
Greenville, South Carolina 29605
United States
Recruiting Deborah Strahs
650-900-4518
Dstrahs@corvuspharma.com
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Site Coordinator
615-329-7274
asksarah@sarahcannon.com
Mary Crowley Cancer Research
Dallas, Texas 75230
United States
Recruiting Study Coordinator
972-566-3000
information@marycrowley.org
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United States
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Recruiting Site Coordinator
414-805-8900
CCCTO@mcw.edu
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Australia
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
St. Vincent's Hospital
Darlinghurst, New South Wales 2010
Australia
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
Westmead Hospital
Westmead, New South Wales 3168
Australia
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
Royal Brisbane and Women's Hospital
Herston, Queensland 4029
Australia
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com
Monash Health
Clayton, Victoria 3168
Australia
Recruiting D Strahs
650-900-4518
DStrahs@corvuspharma.com