Sacituzumab Tirumotecan in Previously Treated TROP2-Positive Advanced Biliary Tract Cancer

This is a single-arm, Phase II, multicenter clinical trial evaluating sacituzumab tirumotecan in patients with TROP2-positive advanced biliary tract cancer who have experienced disease progression after, or intolerance to, at least one prior line of systemic therapy. Eligible participants will receive sacituzumab tirumotecan monotherapy. The primary objective is to evaluate objective response rate as assessed by the investigator according to RECIST version 1.1. Secondary objectives include evaluation of progression-free survival, overall survival, and safety. Exploratory analyses will assess the association between TROP2 protein expression and clinical efficacy, as well as potential mechanisms of resistance.

NCT Number	NCT07701122
Lead Sponsor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Collaborators: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions	Advanced Biliary Tract Cancer(BTC)
Enrollment	33 participants
Start Date	2026-07-01
Primary Completion	2027-07-01 (estimated)
Study Completion	2028-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-14