A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer

The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. The primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. Researchers will compare Suvemcitug + trifluridine/tipiracil tablets with placebo (a look-alike substance that contains no drug)+ trifluridine/tipiracil tablets to see if Suvemcitug + trifluridine/tipiracil tablets works better in treating refractory metastatic colorectal cancer.

NCT Number	NCT07361003
Lead Sponsor	Jiangsu Simcere Pharmaceutical Co., Ltd. Collaborators: Jiangsu Simcere Biologics Co., Ltd
Conditions	Refractory Metastatic Colorectal Cancer
Enrollment	464 participants
Start Date	2025-11-12
Primary Completion	2028-01 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-01-22