NCT02655822

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Corvus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Renal Cell Cancer
• Metastatic Castration Resistant Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-06-01
• Completion: 2021-07-01
• First posted: 2016-01-14
• Last updated: 2021-08-30

Locations

20 sites across 3 countries: United States, Australia, Canada