A Phase Ib/II Study of BBI608 in Combination with Pembrolizumab in Patients with Metastatic Colorectal Cancer

Interventions: 1 cycle is 21days. BBI608: Oral administration at a dose of 240mg or 480 mg BID, every day Pembrolizumab: Administration at a dose of 200 mg/body on Day 1 of each cycle The therapy will be repeated until meeting the discontinuation criteria. [Additional cohort to the Phase II part] BBI608: Oral administration at a dose of 240 mg BID, every day Pembrolizumab: Administration at a dose of 200 mg/body on Day 1 of each cycle.
Primary outcome(s): Immune-related objective response rate (irORR) determined by their Response Evaluation Criteria In Solid Tumors (irRECIST) [Additional cohort to the Phase II part] Objective response rate determined by the RECIST version 1.1
Study Design: Single arm Non-randomized