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

StatusRecruiting
PhasePhase 3
Started2025-03-25
View on ClinicalTrials.gov ↗

Amendment history

2026-04-15
Study Identification, Study Status v4
Study title+17 characters
[...] n Patients With Recurrent or Metastatic Urothelial Carcinoma(PANKU-Bladder01)
2025-09-11
Study Status, Study Design v3
Enrollment target674→508
2025-04-30
Study Status, Arms and Interventions v2
Re-verified, no change to tracked fields
2025-04-16
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03→confirmed 2025-03-25
Eligibility criteria-18 characters
Inclusion Criteria: Sign the informed consent form voluntarily and follow the protocol requirements; Age: ≥18 years old and ≤75 years old; Expected survival time ≥3 months; Patients with unresectab [...]
Study sitesdetails revised at 1 of 1 site
2025-02-26
Original filing
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.
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