NCT07361003

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 464 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will enroll approximately 464 participants (30 for Phase Ib and 434 for Phase III stage) with refractory metastatic colorectal cancer who have previously received fluorouracil, oxaliplatin, and irinotecan-based chemotherapy, and who have either previously received or are unsuitable for anti-vascular endothelial growth factor (VEGF) therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type). For Phase Ib Study, all 30 participants will be receiving the treatment with Suvemcitug in combination with trifluridine/tipiracil tablets. For Phase III Study, approximately 434 participants will be randomly assigned in a 1:1 ratio to two groups. One group will receive treatment with Suvemcitug + trifluridine/tipiracil tablets. The other group will receive the treatment with placebo + trifluridine/tipiracil tablets. All participants will receive study treatment until they meet the criteria for treatment discontinuation. During study treatment period, investigators will evaluate the efficacy, safety and participants' quality of life. After treatment discontinuation, investigators will continue to follow up for subsequent treatment and survival information until the criteria for study discontinuation are met. By the end of study, for participants who are still receiving study treatment, if their efficacy evaluation result is stable or response and they are tolerant to the treatment, then after obtaining approval from health regulatory authorities and ethics committees, they can continue study treatment by joining another extension study or in other ways as discussed by the sponsor.

Conditions

• Refractory Metastatic Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-12
• Primary completion: 2028-01-01
• Completion: 2028-07-01
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

6 sites across 1 country: China