drugset / Trial / NCT06857175
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)
Phase 3
Recruiting
508 enrolled
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is a registered phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic urothelial carcinoma after failure of PD-1/PD-L1 monoclonal antibody and platinum-based chemotherapy.
Timeline
- Start
- 2025-03-25
- Primary completion
- 2027-06
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | — | Intravenous |
| Subject | Izalontamab Brengitecan | Unknown | — | Intravenous |
| Comparator | Paclitaxel | Small molecule | — | Intravenous |