LB-100 (PP2A Inhibitor) and Atezolizumab (PD-L1 Inhibitor) in Metastatic Colorectal Cancer Patients

The goal of this Phase Ib monocenter, open-label, non-randomized clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the combination of LB-100 and atezolizumab in patients with metastatic microsatellite stable colorectal cancer. This study will consist of a dose escalation phase and a dose expansion phase. The dose escalation phase is designed to find the recommended phase II dose of LB-100 in combination with atezolizumab standard dosage of 1200 mg. The dose expansion phase further explores the clinical activity, safety, tolerability and pharmacokinetics/dynamics of LB-100 combined with atezolizumab. LB-100 will be administered intravenously on day 1 and day 3 of every 21-day cycle. Atezolizumab 1200 mg will be administered intravenously on day 1 of every 21-day cycle, which is the labelled dose as monotherapy. Clinical assessments will be performed routinely to monitor safety. Anti-tumor activity will be measured by CT scan according to RECIST version 1.1 criteria. Tumor biopsies will be obtained for exploratory objectives.