RASTRIC-trial: investigating the safety and efficacy of a new three drug treatment combination for RAS-mutated metastastic colorectal cancer.

Primary objectives: Phase I The main objective of the phase I part is to determine safety and the recommended phase II dose (RP2D) of the triple combination. Phase II The main objective of the phase II part is to determine efficacy of the triplet combination defined by objective response rate according to RECIST 1.1. Primary endpoints: For the phase I dose-escalation trial: The primary endpoint is the incidence of DLTs leading to a RP2D. The RP2D of the triplet will be the MTD which is defined as the dose level that can be given to 6 subjects such that not more than 1 subject experiences a DLT. For the phase II trial: The primary endpoint is best overall response (OR), defined as complete response (CR) + partial response (PR) within 6 months, based on RECIST 1.1.