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Study of T-DXd and Rilvegostomig for HER2-expressing Biliary Tract Cancer

This study is testing two experimental drugs, Trastuzumab deruxtecan (T-DXd) and Rilvegostomig, alone or together, against standard treatments for advanced biliary tract cancer. Standard treatments include Gemcitabine, Cisplatin, and Durvalumab. You might be able to join if you are 18 or older, have advanced biliary tract cancer that hasn't been treated before, and your cancer has a specific biomarker (HER2). Researchers want to see if the experimental drugs are safe and how well they work to extend life compared to standard care. The study will also look at how well the experimental drugs work in people whose cancer has a high level of HER2.

Study design
This interventional study plans to enroll 620 participants. It compares experimental therapies to standard of care treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to assess overall survival for up to 50 months after the first person joins the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06467357

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

Recruiting
PHASE3Ages 18–99InterventionalTreatment
AstraZeneca
~620 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:GemcitabineCisplatinDurvalumabTrastuzumab deruxtecanRilvegostomig

At a glance

Recruiting sites
229 of 269 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig
Measured over Until all patients have completed at least 1 full Cycle (each cycle is 21 days)
+1 more outcome measured

Conditions

Biliary Tract Cancer

Explore related trials

Malignant neoplasm of biliary tract

NCT06467357

Where you'd take part

This study runs at 269 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Scottsdale, Arizonano site contact published

    Recruiting

  • Research Site

    Tucson, Arizonano site contact published

    Recruiting

  • Research Site

    Fullerton, Californiano site contact published

    Recruiting

  • Research Site

    La Jolla, Californiano site contact published

    Recruiting

  • Research Site

    Los Angeles, Californiano site contact published

    Recruiting

  • Research Site

    Los Angeles, Californiano site contact published

    Recruiting

  • Research Site

    San Francisco, Californiano site contact published

    Recruiting

  • Research Site

    Walnut Creek, Californiano site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Eligibility criteria

Inclusion

Male and female patients must be at least 18 years of age at the time of signing the informed consent. Other age restrictions may apply as per local regulations.
Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is \> 3 months (90 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.
Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.
Patients must provide an FFPE tumor sample that is no older than 3 years for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 status, and other correlatives.
Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (Randomized portion only)
WHO/ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
Adequate organ and bone marrow function within 14 days before randomization.
Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.
Minimum life expectancy of 12 weeks.

Exclusion

Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines.
Histologically confirmed ampullary carcinoma.
Any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the Investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results.
Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
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.
Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.
Active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening.
Corrected QT interval (QTcF) prolongation to \> 470 msec (females) or \> 450 msec (males) based on average of the screening triplicate 12-lead ECG.
History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion etc).
Prior pneumonectomy (complete).
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. Patients with prior cholangitis/biliary tract infections/biliary intervention (eg, stent, external drain) should have completed a full course of antibiotics prior to randomization.
Active primary immunodeficiency, known uncontrolled active HIV infection or HCV.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected nonmelanoma skin cancer and curatively treated in situ disease. For certain participant populations, exceptions could also include carcinomas in-situ or Ta tumors treated with curative intent.
Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (Drainage and Cell free and Concentrated Ascites Reinfusion Therapy are not allowed within 2 weeks prior to screening assessment).
Any concurrent anticancer treatment without an adequate washout period prior to randomization. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is allowed.
History of organ transplants or allogenic stem cell transplant.

What this trial measures

  • Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomigUntil all patients have completed at least 1 full Cycle (each cycle is 21 days)

    Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0.

  • Randomized Portion: To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care (SoC) in terms of Overall Survival in the FAS (HER2 IHC 3+) populationFrom date of treatment randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)

    Overall survival (OS) in FAS (HER2 IHC 3+) population OS is defined as time from randomization date until the date of death due to any cause. The comparison will include all randomized patients, regardless of whether the patient withdraws from therapy or receives another anticancer therapy. The measure of interest is the hazard ratio of OS.