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A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)

StatusRecruiting
PhasePhase 3
Started2026-06-29
View on ClinicalTrials.gov ↗

Amendment history

2026-07-23
Study Status, Contacts/Locations v3
Recruitment opened
Start dateestimated 2026-07→confirmed 2026-06-29
Study sitesdetails revised at 1 of 1 site
2026-06-29
Study Identification, Study Status, Study Description v2
Start date2026-05→2026-07
Study title-43 characters
[...] ry Tract Cancer After Failure of Platinum-based Chemotherapy and PD-1/PD-L1 Monoclonal Antibody Therapy(PANKU-BTC01)
2026-05-19
Study Status, Arms and Interventions v1
Re-verified, no change to tracked fields
2026-05-06
Original filing
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or metastatic biliary tract cancer who have failed prior platinum-based chemotherapy.
Trial Details
NCT Number NCT07582315
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Biliary Tract Cancer
Enrollment 538 participants
Start Date 2026-06-29
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-24