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RECRUITING
NCT07361003
PHASE3

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

Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

Suvemcitug injection, trifluridine/tipiracil tablets

Suvemcitug injection at 1.5mg/kg, Trifluridine/tipiracil tablets at 35 mg/m²

DRUG

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