This is a phase 1/1b open-label, multicenter, dose-selection study of ciforadenant, 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 ciforadenant as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. Ciforadenant 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 ciforadenant, 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 ciforadenant as a single agent and in combination with atezolizumab, an intravenous PD-L1 inhibitor. Ciforadenant blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
502
100 mg orally twice daily for the first 14 days of each 28-day cycle.
100 mg orally twice daily for 28 days of each 28-day cycle.
200 mg orally once daily for the first 14 days of each 28-day cycle.
Ciforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.
Start with 150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.
University of Arizona Cancer Center
Tucson, Arizona, United States
University of California - San Francisco
San Francisco, California, United States
Stanford Cancer Institute
Stanford, California, United States
Yale University
New Haven, Connecticut, United States
University of Miami Hospital and Clinics
Miami, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
...and 10 more locations
Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab
Time frame: 28 days following first administration of ciforadenant
Objective response rate per RECIST v1.1 criteria of ciforadenant as a single agent and in combination with atezolizumab
Time frame: From start of treatment to end of treatment, up to 72 months
Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.4.03, of ciforadenant as a single agent and in combination with atezolizumab
Time frame: Continuously, up to 72 months
Mean and median Area under the curve (AUC) of ciforadenant
Time frame: Up to 12 months
Mean and median Maximum concentration (Cmax) of ciforadenant
Time frame: Up to 12 months
Identify the MDL (maximum dose level) of single agent ciforadenant
Time frame: From start of treatment to end of treatment, up to 72 months.
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