NCT06467357

Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 620 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Standard of care chemotherapy by intravenous infusion
DRUG	Cisplatin	Standard of care chemotherapy by intravenous infusion
DRUG	Durvalumab	Standard of care immunotherapy by intravenous infusion
DRUG	Trastuzumab deruxtecan	Experimental therapy by intravenous infusion
DRUG	Rilvegostomig	Experimental therapy by intravenous infusion

Timeline

• Start date: 2024-08-12
• Primary completion: 2028-06-12
• Completion: 2029-05-16
• First posted: 2024-06-21
• Last updated: 2026-04-16

Locations

266 sites across 27 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hong Kong, India, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Saudi Arabia, Slovakia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study