Clinical Trial

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-02-26; most recent amendment 2026-04-15.
Status change: Not Yet Recruiting → Recruiting 2025-04-16
Trial Details
NCT Number NCT06857175
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Urothelial Carcinoma
Enrollment 508 participants
Start Date 2025-03-25
Primary Completion 2027-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-20