OncoMatch/Clinical Trials/NCT06467357

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

Is NCT06467357 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for biliary tract cancer.

Phase 3RecruitingAstraZenecaNCT06467357Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression (ihc 3+ or ihc 2+)

Performance status

WHO/ECOG 0–1

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: her2-targeted therapy

Cannot have received: antibody-drug conjugate

Cannot have received: immune checkpoint inhibitor

Cannot have received: therapeutic anticancer vaccine

Lab requirements

Blood counts

Adequate organ and bone marrow function within 14 days before randomization.

Kidney function

Adequate organ and bone marrow function within 14 days before randomization.

Liver function

Adequate organ and bone marrow function within 14 days before randomization.

Cardiac function

No clinically significant cardiac conditions; no myocardial infarction within 6 months; no symptomatic congestive heart failure (NYHA II-IV); no unstable angina; no clinically important arrhythmias; no recent (<6 months) cardiovascular event including stroke.

Adequate organ and bone marrow function within 14 days before randomization. Medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke.

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 →

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