OncoMatch/Clinical Trials/NCT06467357
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
Official title: 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
Is NCT06467357 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments for biliary tract cancer.
Treatment: Gemcitabine · Cisplatin · Durvalumab · Trastuzumab deruxtecan · Rilvegostomig — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+ or ihc 2+)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: HER2-targeted therapy
Prior exposure to other HER2 targeting therapies
Cannot have received: antibody-drug conjugate
Prior exposure to ... ADCs
Cannot have received: immune checkpoint inhibitor
Prior exposure to ... immune checkpoint inhibitors
Cannot have received: therapeutic anticancer vaccine
Prior exposure to ... therapeutic anticancer vaccines
Lab requirements
Blood counts
adequate organ and bone marrow function within 14 days before randomization
Kidney function
Liver function
Adequate organ and bone marrow function within 14 days before randomization
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Scottsdale, Arizona
- Research Site · Tucson, Arizona
- Research Site · Tucson, Arizona
- Research Site · Fullerton, California
- Research Site · La Jolla, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06467357 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior HER2-targeted therapy, antibody-drug conjugate, immune checkpoint inhibitor disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 99 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify