drugset
drugset / Trial / NCT07670273

Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer

NCT07670273 ↗

Phase 2 Recruiting 70 enrolled Peking Union Medical College Hospital
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR). Key secondary objectives include efficacy endpoints-progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DoR)-and safety assessments comprising adverse events (AEs), serious adverse events (SAEs), vital signs, and laboratory findings.

Timeline

Start
2026-04-29
Primary completion
2027-04-29
Completion
2028-04-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebrelimab Monoclonal antibody 1200 mg Intravenous
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Trastuzumab Rezetecan Monoclonal antibody 4.8 mg/kg Intravenous
Subject Trastuzumab Rezetecan Monoclonal antibody 408 mg Intravenous

Indications

biliary tract cancer