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

Official Title

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

Summary:

This is a phase 1/1b open-label, multicentre, 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-tumour activity of CPI-444 as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumours. CPI-444 blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumour activity of T cells and other immune cells.

Trial Description

Primary Outcome:

• Incidence of dose-limiting toxicities (DLTs) of CPI-444 as a single agent and in combination with atezolizumab
• Objective response rate per RECIST v1.1 criteria of CPI-444 as a single agent and in combination with atezolizumab
• 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
• Mean and median Area under the curve (AUC) of CPI-444
• Mean and median Maximum concentration (Cmax) of CPI-444
• Identify the MDL (maximum dose level) of single agent CPI-444

This is a phase 1/1b open-label, multicentre, 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-tumour 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-tumour activity of T cells and other immune cells.

View this trial on ClinicalTrials.gov