Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Colorectal Cancer, Colorectal Cancer, Skin Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/14/2018
Start Date:January 2016
End Date:October 2021
Contact:Director, Clinical Operations
Email:inquiry@corvuspharma.com
Phone:650-900-4520

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A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of CPI-444 as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers

This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small
molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune
system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as
a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid
tumors. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the
anti-tumor activity of T cells and other immune cells.

This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, an oral small
molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune
system. This trial will study the safety, tolerability, and anti-tumor activity of CPI-444 as
a single agent and in combination with atezolizumab, an intravenous PD-L1 inhibitor. CPI-444
blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor
activity of T cells and other immune cells.

Inclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

2. Documented incurable cancer with one of the following histologies: non-small cell lung
cancer, malignant melanoma, renal cell cancer, triple negative breast cancer,
colorectal cancer with microsatellite instability (MSI), bladder 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.

Exclusion Criteria

1. History of severe hypersensitivity reaction to monoclonal antibodies.

2. Any active autoimmune disease or a documented history of serious autoimmune disease
within the past 5 years requiring immunosuppressive therapy.

3. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or clinical symptoms of active pneumonitis.

4. The use of any investigational medication or device in the 30 days prior to screening
and throughout the study is prohibited.

5. If a patient is currently receiving denosumab, this must be discontinued prior to
enrollment. Substitution with biphosphonates are acceptable.
We found this trial at
27
sites
Brisbane, Queensland
Principal Investigator: Brett Hughes, MBBS, FRACP
Phone: +61 7 3646 8111
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Rebecca Heist, MD
Phone: 617-726-2000
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Saby George, MD
Phone: 877-275-7724
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Dale R Shepard, MD
Phone: 866-223-8100
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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9801 W. Kincey Ave
Huntersville, North Carolina 28078
704-947-6599
Principal Investigator: John Powderly, MD
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Taofeek Owonikoko, MD
Phone: 404-778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Aurora, Colorado 80045
Principal Investigator: Robert Doebele, MD
Phone: 720-262-9994
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Baltimore, Maryland 21287
Principal Investigator: Patrick Forde, MD
Phone: 410-955-5222
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Jason Luke, MD
Phone: 855-702-8222
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Philip Bonomi, MD
Phone: 312-942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Erin Bertino, MD
Phone: 614-293-4376
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Dallas, Texas 75246
Principal Investigator: Minal Barve, MD
Phone: 972-566-3000
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Kevin Courtney, MD
Phone: 214-645-4673
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Detroit, Michigan 48201
Principal Investigator: Amy Weise, DO
Phone: 800-527-6266
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Jonathan Goldman, MD
Phone: 310-825-5268
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Matthew Riese, MD
Phone: 414-805-8200
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Mario Sznol, MD
Phone: 203-785-4095
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Joshua Brody, MD
Phone: 212-659-5600
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Richard Carvajal, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Matthew Hellmann, MD
Phone: 800-525-2225
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Lyudmyla Berim, MD
Phone: 402-559-5600
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Pittsburgh, Pennsylvania 15213
Principal Investigator: James Lee, MD
Phone: 412-647-2811
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Leonel Hernandez-Aya, MD
Phone: 800-600-3606
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94143
Principal Investigator: Lawrence Fong, MD
Phone: 800-444-2559
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Stanford, California 94305
Principal Investigator: Shivaani Kummar, MD
Phone: 650-723-2300
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Tucson, Arizona 85724
Principal Investigator: Daruka Mahadevan, MD
Phone: 520-694-2873
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Principal Investigator: Stephen Liu, MD
Phone: 202-444-2223
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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