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

Summary

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.

Timeline

Start

2026-07-01

Primary completion

2027-07-01

Completion

2028-07-01

Drugs

Indications