drugset / Trial / NCT07361003
A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
Phase 3
Recruiting
464 enrolled
Jiangsu Simcere Pharmaceutical Co., Ltd.
Jiangsu Simcere Biologics Co., Ltd · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-11-12
- Primary completion
- 2028-01
- Completion
- 2028-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Suvemcitug | Monoclonal antibody | 1.5 mg/kg | Other |
| Background | Trifluridine/tipiracil | Unknown | 35 mg/m2 | — |
| Comparator | Trifluridine/tipiracil | Unknown | 35 mg/m2 | — |