drugset / Trial / NCT06630871
A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.
Phase 2
Not yet recruiting
40 enrolled
Fujian Medical University Union Hospital
BeiGene · collabRemeGen Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment of high-risk, very high-risk NMIBC with HER2 2+-3+.
Timeline
- Start
- 2024-10
- Primary completion
- 2026-10
- Completion
- 2028-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Disitamab Vedotin | Monoclonal antibody | 2 mg/kg | — |
| Subject | Disitamab Vedotin | Monoclonal antibody | 120 mg | — |
| Subject | Tislelizumab | Monoclonal antibody | — | — |