Phase 2b Study Comparing DSP107 with Atezolizumab Versus Fruquintinib for Advanced Microsatellite Stable Colorectal Cancer

What this Trial Is About

Researchers are evaluating a new combination of medicines, DSP107 and atezolizumab, compared with an existing treatment, fruquintinib, for patients with advanced microsatellite stable colorectal cancer. This Phase 2b, randomized, open-label study focuses on individuals whose cancer has progressed or who cannot tolerate standard therapies. The study aims to assess whether the new combination improves treatment outcomes and safety compared to the current treatment options. Participants are randomly assigned to one of two groups. One group receives DSP107 intravenously on Days 1, 8, and 15 of each 28-day cycle with atezolizumab given intravenously on Day 1. The other group takes fruquintinib orally once daily on Days 1 to 21 of each 28-day cycle. The study includes a screening period of up to 28 days, a treatment period lasting up to 24 cycles, a safety follow-up period of up to 90 days after the last dose, and a long-term follow-up lasting up to 5 years from randomization. During the study, participants will have medical evaluations including monitoring of cancer response, safety assessments, and tests such as ECG and blood pressure measurements. Quality of life and immune response to treatment will also be tracked. Participants maintain dosing diaries if assigned to the oral treatment group. The primary outcome is overall survival, with ongoing safety and health status follow-up conducted for several years after treatment. Total study participation duration varies based on treatment tolerability and disease progression.

A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.