drugset / Trial / NCT05943379
RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects
Non-randomizedSingle-groupOpen-labelTreatment
Summary
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in combination with gemcitabine.
Timeline
- Start
- 2023-06-08
- Primary completion
- 2025-12-01
- Completion
- 2026-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Disitamab Vedotin | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg | Other |