A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
A Phase Ib/III Study of Suvemcitug Plus Trifluridine/Tipiracil Tablets (FTD/TPI) Versus Placebo Plus Trifluridine/Tipiracil Tablets in Participants With Refractory Metastatic Colorectal Cancer
Jiangsu Simcere Pharmaceutical Co., Ltd.
464 participants
Nov 12, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Suvemcitug injection at 1.5mg/kg, Trifluridine/tipiracil tablets at 35 mg/m²
Suvemcitug placebo injection, Trifluridine/tipiracil tablets at 35 mg/m².
Locations(6)
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NCT07361003