Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06467357 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

NCT06467357 · ClinicalTrials.gov record · last posted 2026-08-19

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

Name: Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer — clinical trial record (NCT06467357)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: DESTINY-BTC01

StatusRecruiting

PhasePhase 3

SponsorAstraZeneca

Started2024-08-12

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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.

Protocol amendment history 2 changes detected by DataLookout

2026-05-15

Trial sites expanded: 266 → 270 locations

2026-04-17

Trial sites expanded: 263 → 266 locations

Trial Details

NCT Number	NCT06467357
Lead Sponsor	AstraZeneca
Conditions	Biliary Tract Cancer
Enrollment	620 participants
Start Date	2024-08-12
Primary Completion	2028-06-12 (estimated)
Study Completion	2029-05-16 (estimated)
Updated on ClinicalTrials.gov	2026-08-19