drugset / Trial / NCT07100184

RC48 in Combination With Radiotherapy for HER2-Expressing NMIBC Patients

NCT07100184

Phase 2 Not yet recruiting 30 enrolled Peking University First Hospital RemeGen Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment

Summary

This study is an open, single-arm, single-center exploratory clinical study to explore the efficacy and safety of Disitamab Vedotin (RC-48) in combination with radiotherapy for the treatment of patients with HER2-expressing high-risk or very high-risk non-muscle invasive bladder cancer (NMIBC) without visible foci of disease after transurethral resection of bladder tumor (TURBT). The study plans to enroll 30 patients with high or very high risk HER2-expression NMIBC without visible lesions after TURBT. The study includes a screening period, a treatment period, and a survival follow-up period. This is a single-center study conducted at the Peking University First Hospital, and the PI is Prof. CuiJian Zhang.

Timeline

Start
2025-09-01
Primary completion
2028-05-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Disitamab Vedotin Monoclonal antibody 2 mg/kg

Indications

No indication recorded.