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A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
464
Start Date
2025-11-12
Completion Date
2028-07
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
Suvemcitug injection, trifluridine/tipiracil tablets
Suvemcitug injection at 1.5mg/kg, Trifluridine/tipiracil tablets at 35 mg/m²
Suvemcitug placebo injection, trifluridine/tipiracil tablets
Suvemcitug placebo injection, Trifluridine/tipiracil tablets at 35 mg/m².
Locations (6)
Fujian Cancer Hospital
Fuzhou, Fujian, China
Harbin Medical University University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China