CPI-006 Alone and in Combination With CPI-444 and With Pembrolizumab for Patients With Advanced Cancers



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Lymphoma, Women's Studies, Endometrial Cancer, Pancreatic Cancer, Bladder Cancer
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:April 25, 2018
End Date:December 2023

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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

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 and Non-Hodgkin lymphoma.

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 and Non-Hodgkin lymphoma. This trial is composed of dose escalation and dose
expansion cohorts.

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.
We found this trial at
12
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Jason Luke, MD
Phone: 773-702-1835
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Igor Puzanov, MD
Phone: 716-845-8474
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Jaime Merchan, MD
Phone: 305-243-0865
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Toni Choueiri, MD
Phone: 617-632-2355
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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7777 Forest Lane
Dallas, Texas 75230
Principal Investigator: Minal Barve, MD
Phone: 972-566-3000
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Dallas, TX
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Duarte, California 91010
Principal Investigator: Sumanta Pal, MD
Phone: 629-218-0979
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Duarte, CA
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Huntsville, North Carolina 28078
Principal Investigator: John Powderly
Phone: 704-947-6599
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Huntsville, NC
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Milwaukee, Wisconsin
Principal Investigator: Matthew Riese, MD
Phone: 414-805-8900
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Milwaukee, WI
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Melissa Johnson, MD
Phone: 615-329-7274
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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New Haven, Connecticut 06520
Principal Investigator: Patricia LoRusso, MD
Phone: 203-785-3482
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New Haven, CT
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Thomas Marron, MD
Phone: 212-824-7309
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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New York, NY
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Oklahoma City, Oklahoma 73104
Principal Investigator: Abhishek Tripathi, MD
Phone: 405-271-1112
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Oklahoma City, OK
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