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A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure

StatusRecruiting
PhasePhase 3
Started2026-07-07
View on ClinicalTrials.gov ↗

Amendment history

2026-07-23
Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-05→confirmed 2026-07-07
Study sitesdetails revised at 2 of 2 sites
2026-05-19
Original filing
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing locally advanced or metastatic biliary tract cancer after platinum-containing chemotherapy failure.
Trial Details
NCT Number NCT07606599
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Biliary Tract Cancer
Enrollment 398 participants
Start Date 2026-07-07
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-24