Objectives

MoTriColor proposes to perform 3 two-stage single arm multi-centre open-label Phase II studies in molecular- and gene expression-selected mCRC populations addressing the following primary objectives:

  • To determine the anti-tumour activity of the experimental treatments, as measured by overall response rate (ORR) in each molecularly selected patient population for each study.
  • To characterize the safety and tolerability of these experimental treatments, as assessed by the incidence and severity of adverse events (AEs).
  • To determine other anti-tumour activity parameters like progression-free-survival (PFS), clinical benefit (CB), duration of response, time to response and overall survival (OS).

Complementary to the mentioned milestones, MoTriColor also has the following specific secondary objectives, related to the clinical assays:

  • To explore the potential mechanism of response and of primary and/or secondary resistance to the experimental treatments.
  • Monitoring of circulating tumour DNA (ctDNA) in the blood.