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

NCT06467357 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2026-05-14

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2028-06-12
Completion
2029-05-16
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06467357 on ClinicalTrials.gov