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

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

INTRODUCTION

  • Org Study ID: CPI-444-001
  • Secondary ID: N/A
  • NTC ID: NCT02655822
  • Sponsor: Corvus Pharmaceuticals, Inc.

BRIEF SUMMARY


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.

DETAILED DESCRIPTION


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.


  • Overall Status
    Recruiting
  • Start Date
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of dose-limiting toxicities (DLTs) of CPI-444 as a single agent and in combination with atezolizumab

Primary Outcome 1 - Timeframe: 28 days following first administration of CPI-444

Primary Outcome 2 - Measure: Objective response rate per RECIST v1.1 criteria of CPI-444 as a single agent and in combination with atezolizumab

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

Primary Outcome 3 - Measure: Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.4.03, of CPI-444 as a single agent and in combination with atezolizumab

Primary Outcome 3 - Timeframe: Continuously, up to 36 months

Primary Outcome 4 - Measure: Mean and median Area under the curve (AUC) of CPI-444

Primary Outcome 4 - Timeframe: Day 14 of Cycle 1

Primary Outcome 5 - Measure: Mean and median Maximum concentration (Cmax) of CPI-444

Primary Outcome 5 - Timeframe: Day 14 of Cycle 1

Primary Outcome 6 - Measure: Identify the MDL (maximum dose level) of single agent CPI-444

Primary Outcome 6 - Timeframe: From start of treatment to end of treatment, up to 36 months.

CONDITION

  • Non-Small Cell Lung Cancer
  • Malignant Melanoma
  • Renal Cell Cancer
  • Triple Negative Breast Cancer
  • Colorectal Cancer
  • Bladder Cancer
  • Metastatic Castration Resistant Prostate Cancer

ELIGIBILITY


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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: C Clark

Role: Study Director

Affiliation: Corvus Pharmaceuticals

Overall Contact

Name: C Clark

Phone: 650-900-4520

Email: inquiry@corvuspharma.com

LOCATION

Facility Status Contact
Facility: University of Arizona Cancer Center
Tucson, Arizona 85719
United States
Status: Recruiting Contact:
Study Coordinator
520-694-2873
Facility: UCLA Medical Center
Los Angeles, California 90095
United States
Status: Recruiting Contact:
Study Coordinator
310-825-5268
Facility: University of California - San Francisco
San Francisco, California 94143
United States
Status: Recruiting Contact:
Study Coordinator
800-444-2559
Facility: Stanford Cancer Institute
Stanford, California 94305
United States
Status: Recruiting Contact:
Study Coordinator
650-723-2300
Facility: University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Status: Recruiting Contact:
Study Coordinator
720-262-9994
Facility: Yale University
New Haven, Connecticut 06510
United States
Status: Recruiting Contact:
Study Coordinator
203-785-4095
Facility: Georgetown University
Washington, District of Columbia 20057
United States
Status: Recruiting Contact:
Study Coordinator
202-444-2223
Facility: University of Miami Hospital and Clinics
Miami, Florida 33136
United States
Status: Recruiting Contact:
Study Coordinator
305-243-1000
Facility: Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact:
Study Coordinator
404-778-1900
Facility: Rush University Medical Center
Chicago, Illinois 60612
United States
Status: Recruiting Contact:
Study Coordinator
312-942-5000
Facility: University of Chicago Medical Center
Chicago, Illinois 60637
United States
Status: Recruiting Contact:
Study Coordinator
855-702-8222
Facility: Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University School of Medicine
Baltimore, Maryland 21287
United States
Status: Recruiting Contact:
Study Coordinator
410-955-5222
Facility: Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Status: Recruiting Contact:
Study Coordinator
617-726-2000
Facility: Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Status: Recruiting Contact:
Study Coordinator
800-527-6266
Facility: Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact:
Study Coordinator
800-600-3606
Facility: University of Nebraska Medical Center
Omaha, Nebraska 68154
United States
Status: Recruiting Contact:
Study Coordinator
402-559-5600
Facility: Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Status: Recruiting Contact:
Study Coordinator
877-275-7724
askrpci@roswellpark.org
Facility: Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Status: Recruiting Contact:
Study Coordinator
212-659-5600
Facility: Columbia University Medical Center
New York, New York 10032
United States
Status: Recruiting Contact:
Study Coordinator

sm3011@cumc.columbia.edu
Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact:
Study Coordinator
800-525-2225
Facility: Carolina BioOncology Institute
Huntersville, North Carolina 28078
United States
Status: Recruiting Contact:
Ashley McClain
704-947-6599
Facility: Cleveland Clinic
Cleveland, Ohio 44195
United States
Status: Recruiting Contact:
Study Coordinator
866-223-8100
Facility: University of Pittsburgh Medical Center Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact:
Study Coordinator
412-647-2811
Facility: Mary Crowley Cancer Research Centers
Dallas, Texas 75251
United States
Status: Recruiting Contact:
Study Coordinator
972-566-3000
Facility: University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Status: Recruiting Contact:
Study Coordinator
214-645-4673
Facility: Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact:
Study Coordinator
414-805-8200
Facility: Royal Brisbane and Women's Hospital
Brisbane, Queensland 4029
Australia
Status: Recruiting Contact:
Study Coordinator
+61 7 3646 8111
Facility: Monash Health
Clayton, Victoria 3168
Australia
Status: Recruiting Contact:
Study Coordinator
(03) 9594 6666
Facility: Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
Status: Recruiting Contact:
Study Coordinator
+1 780-432-8771
Facility: British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia V5Z 4E6
Canada
Status: Recruiting Contact:
Study Coordinator
+1 604-877-6000
Facility: The Ottawa Hospital Cancer Centre
Ottawa, Ontario K1H 8L6
Canada
Status: Recruiting Contact:
Study Coordinator
613-761-4295