NCT06857175

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma After Failure of PD-1/PD-L1 Monoclonal Antibody and Platinum-based Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 508 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	BL-B01D1	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Docetaxel or Paclitaxel	Administration by intravenous infusion for a cycle of 3 weeks.

Timeline

• Start date: 2025-03-25
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-03-04
• Last updated: 2025-09-12

Locations

1 site across 1 country: China