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BRIEF TITLE: A Phase 1/1b Multicenter 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, In Combination With CPI-444, And In Combination With 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, multicenter, dose-selection study of CPI-006, a Type 2 humanized IgG1 antibody inhibiting enzymatic activity of CD73 and adenosine production. This trial will study the safety, tolerability, and anti-tumor activity of CPI-006 as a single agent, in combination with CPI-444, a small molecule targeting the adenosine-A2A receptor on immune cells, and in combination with pembrolizumab, an anti-PD1 antibody against various solid tumors.

Detailed Description


This is a phase 1/1b open label, multicenter, dose-selection study of CPI-006, a Type 2
humanized IgG1 antibody inhibiting enzymatic activity of CD73 and adenosine production. This
trial will study the safety, tolerability, and anti-tumor activity of CPI-006 as a single
agent, in combination with CPI-444, a small molecule targeting the adenosine-A2A receptor on
immune cells, and in combination with pembrolizumab, an anti-PD1 antibody against various
solid tumors. This trial is composed of dose escalation and dose expansion cohorts.

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 CPI-444 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 CPI-444 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

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. At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or
progressing disease.

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: G Luciano

Role: Study Director

Affiliation: Corvus Pharmaceuticals

Locations

Facility Status Contact
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
The University of Chicago
Chicago, Illinois 60637
United States
Recruiting Site Coordinator
773-702-1835
mweist@medicine.bsd.uchicago.edu
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
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Site Coordinator
405-271-1112
SCC-Clinical-Trials-Office@ouhsc.edu
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
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Recruiting Site Coordinator
414-805-8900
CCCTO@mcw.edu