RecruitingPhase 3NCT07361003

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


Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Enrollment

464 participants

Start Date

Nov 12, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a drug called suvemcitug to a standard chemotherapy pill (FTD/TPI, also called trifluridine/tipiracil) works better than current treatments for people with advanced colorectal cancer (bowel cancer that has spread) that has stopped responding to prior therapies. **You may be eligible if...** - You have advanced or metastatic colorectal cancer confirmed by biopsy - Your cancer has at least one measurable tumor - You have already been treated with standard chemotherapy regimens including fluorouracil, oxaliplatin, and irinotecan, and anti-VEGF therapy (and anti-EGFR therapy if your tumor has normal RAS) - Your cancer has progressed or you could not tolerate your last treatment - Your organ and bone marrow function is adequate **You may NOT be eligible if...** - You have another active cancer within the past 5 years - You have active or symptomatic brain metastases - You have uncontrolled fluid buildup in your chest or abdomen - You have had a serious active infection in the past 2 weeks - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSuvemcitug injection, trifluridine/tipiracil tablets

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

DRUGSuvemcitug 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

View Full Details on ClinicalTrials.gov

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NCT07361003


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