drugset / Trial / NCT07506057

Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy

NCT07506057

Phase 2 Recruiting 20 enrolled Xiujuan Qu
NaSingle-groupOpen-labelTreatment

Summary

his single-center phase II clinical study enrolls patients with unresectable locally advanced or metastatic HER2-overexpressing biliary tract cancer or urothelial carcinoma who have failed standard treatment. Participants receive trastuzumab in combination with serplulimab and chemotherapy. The study aims to evaluate the efficacy and safety of this regimen in this patient population. The primary endpoint is objective response rate (ORR). Secondary endpoints include overall survival (OS), progression-free survival (PFS), and safety.

Timeline

Start
2025-07-15
Primary completion
2027-07
Completion
2029-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Serplulimab Monoclonal antibody 4.5 mg/kg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous