drugset / Trial / NCT07646145

Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer

NCT07646145

Phase 2 Recruiting 30 enrolled Shanxi Province Cancer Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression. The goal is to provide a new treatment option for NMIBC patients, reduce the risk of tumor recurrence, decrease the proportion of radical bladder surgery, and improve the quality of life of patients.

Timeline

Start
2024-04-01
Primary completion
2027-04
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Disitamab Vedotin Monoclonal antibody 2 mg/kg Intravenous
Subject Mitomycin C Other / unclassified 40 mg Intravenous