Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers
NCT02655822 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 502
Last updated 2021-08-30
Summary
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.
Conditions
- Renal Cell Cancer
- Metastatic Castration Resistant Prostate Cancer
Interventions
- DRUG
-
Ciforadenant
100 mg orally twice daily for the first 14 days of each 28-day cycle.
- DRUG
-
Ciforadenant
100 mg orally twice daily for 28 days of each 28-day cycle.
- DRUG
-
Ciforadenant
200 mg orally once daily for the first 14 days of each 28-day cycle.
- DRUG
-
Ciforadenant + atezolizumab
Ciforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.
- DRUG
-
Ciforadenant
Start with 150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY -
Corvus Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Mehrdad Mobasher, MD, MPH · Corvus Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2021-06-30
- Completion
- 2021-07-31
Countries
- United States
- Australia
- Canada
Study Locations
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