drugset / Trial / NCT05495724
Disitamab Vedotin Combined With Tislelizumab for Her2 Overexpressing High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a phase II study to determine the safety and efficacy of Disitamab Vedotin when given in combination with Tislelizumab as treatment for patients with Her2 overexpressing high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Patients will receive treatment with Disitamab Vedotin in combination with tislelizumab every 3 weeks for 4 treatment cycles over 12 weeks followed by transurethral resection biopsy.
Timeline
- Start
- 2021-07-23
- Primary completion
- 2025-02
- Completion
- 2025-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Disitamab Vedotin | Monoclonal antibody | 120 mg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |