New hope for bile duct cancer: targeted therapy duo takes on standard chemo

NCT ID NCT06467357

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 4 times

Summary

This study tests whether a new drug combination (trastuzumab deruxtecan plus rilvegostomig) works better than standard chemotherapy for people with advanced bile duct cancer that has a specific protein called HER2. About 620 adults with untreated, advanced HER2-positive bile duct cancer will take part. The goal is to see if the new treatment helps people live longer and has manageable side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 620 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

bile duct adenocarcinoma biliary tract cancer Biliary Tract Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

245 sites in 26 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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Scottsdale, Arizona, 85259, United States
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Tucson, Arizona, 85704, United States
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Tucson, Arizona, 85719, United States
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Fullerton, California, 92835, United States
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La Jolla, California, 92093, United States
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Los Alamitos, California, 90720, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90089, United States
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San Francisco, California, 94143, United States
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Walnut Creek, California, 94598, United States
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Washington D.C., District of Columbia, 20007, United States
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Fort Myers, Florida, 33901, United States
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Jacksonville, Florida, 32224, United States
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St. Petersburg, Florida, 33705, United States
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Tampa, Florida, 33606, United States
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West Palm Beach, Florida, 33401, United States
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Atlanta, Georgia, 30309, United States
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Coeur d'Alene, Idaho, 83814, United States
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Chicago, Illinois, 60612, United States
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Niles, Illinois, 60714, United States
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Towson, Maryland, 21204, United States
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Boston, Massachusetts, 02215, United States
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Worcester, Massachusetts, 01655, United States
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Detroit, Michigan, 48202, United States
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Grand Rapids, Michigan, 49503, United States
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Rochester, Minnesota, 55905, United States
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Kansas City, Missouri, 64132, United States
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St Louis, Missouri, 63110, United States
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Albuquerque, New Mexico, 87102, United States
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New York, New York, 10032, United States
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White Plains, New York, 10601, United States
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Cleveland, Ohio, 44111, United States
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Cleveland, Ohio, 44124, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Greenville, South Carolina, 29605, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76104, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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Pearland, Texas, 77584, United States
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San Antonio, Texas, 78217, United States
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San Antonio, Texas, 78258, United States
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Fairfax, Virginia, 22031, United States
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Fairfax, Virginia, 22031, United States
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Chermside, 4032, Australia
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Clayton, 3168, Australia
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Concord, 2139, Australia
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Nedlands, 6009, Australia
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Graz, 8036, Austria
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Linz, 4010, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Wiener Neustadt, 2700, Austria
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Anderlecht, 1070, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Roeselare, 8800, Belgium
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Natal, 59012-300, Brazil
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Porto Alegre, 90035-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Santa Maria, 97015-450, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 05651-901, Brazil
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Vitória, 29043-272, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Beijing, 100020, China
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Beijing, 100021, China
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Beijing, 100034, China
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Beijing, 100142, China
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Beijing, China
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Bengbu, 233004, China
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Changchun, 130021, China
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Changde, 415000, China
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Changsha, 410005, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610078, China
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Chongqing, 400030, China
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Fuzhou, 350007, China
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Guangzhou, 510080, China
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Guangzhou, 510515, China
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Guiyang, 550044, China
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Hangzhou, 310016, China
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Harbin, 150081, China
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Hefei, 230001, China
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Hefei, 230601, China
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Jinan, 250117, China
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Kunming, 650101, China
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Linyi, 276000, China
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Luoyang, 471000, China
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Nanchang, 330029, China
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Nanjing, 2100008, China
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Nanning, 530021, China
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Nantong, 226001, China
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Shanghai, 200001, China
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Shanghai, 201107, China
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Shanghai, 201114, China
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Shenyang, 110004, China
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Shenzhen, 518116, China
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Tianjin, 300060, China
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Weifang, 261000, China
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Wenzhou, 325035, China
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Wuhan, 430079, China
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Xi'an, 710061, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Brno, 625 00, Czechia
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Brno, 656 53, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 77900, Czechia
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Prague, 100 34, Czechia
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Prague, 15006, Czechia
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Brest, 29609, France
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Clichy, 92118, France
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Dijon, 21079, France
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Lille, 59037, France
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Lyon, 69008, France
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Lyon, 69373, France
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Marseille, 13008, France
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Montpellier, 34295, France
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Pessac, 33604, France
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Villejuif, 94800, France
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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Cologne, 50937, Germany
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Dresden, 01370, Germany
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Frankfurt, 60488, Germany
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Freiburg im Breisgau, 79106, Germany
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Göttingen, 37075, Germany
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Hamburg, 22763, Germany
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Leipzig, 4103, Germany
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Lübeck, 23538, Germany
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München, 81377, DE, Germany
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Ulm, 89081, Germany
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Würzburg, 97080, Germany
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Hong Kong, 999077, Hong Kong
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Shatin, 00000, Hong Kong
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Dehradun, 248016, India
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Delhi, 110029, India
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Delhi, 110088, India
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Kanpur, 208001, India
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Kolkata, 700054, India
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Kolkata, 700094, India
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Mumbai, 400012, India
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Vadodara, 391760, India
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Varanasi, 221005, India
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Florence, 50134, Italy
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Milan, 20132, Italy
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Milan, 20162, Italy
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Naples, 80128, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Roma, 00133, Italy
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Rozzano, 20089, Italy
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Tricase, 73039, Italy
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Bunkyō City, 113-8431, Japan
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Bunkyō City, 113-8603, Japan
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Bunkyō City, 113-8677, Japan
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Chiba, 260-0877, Japan
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Fukuyama-shi, 721-8511, Japan
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Hirakata-shi, 573-1191, Japan
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Hiroshima, 734-8551, Japan
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Kanazawa, 920-8641, Japan
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Kashiwa, 227-8577, Japan
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Kawasaki-shi, 216-8511, Japan
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Kita-gun, 761-0793, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Kyoto, 606-8507, Japan
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Maebashi, 371-8511, Japan
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Mitaka-shi, 181-8611, Japan
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Nagoya, 464-8681, Japan
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Nagoya, 466-8560, Japan
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Osaka, 541-8567, Japan
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Osaka, 545-8586, Japan
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Sakaishi, 591-8025, Japan
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Sapporo, 060-8543, Japan
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Sendai, 980-8574, Japan
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Shinjuku-ku, 160-8582, Japan
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Suita, 565-0871, Japan
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Sunto-gun, 411-8777, Japan
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Ube-shi, 755-8505, Japan
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Wakayama, 641-8510, Japan
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Yokohama, 241-8515, Japan
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George Town, 10990, Malaysia
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Johor Bahru, 81100, Malaysia
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Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuching, 93586, Malaysia
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WITHDRAWN

Rotterdam, 3015 GD, Netherlands
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NOT_YET_RECRUITING

Cebu City, 6000, Philippines
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Makati, 1229, Philippines
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Pasig, 1605, Philippines
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Quezon City, 1112, Philippines
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Bialystok, 15-027, Poland
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Katowice, 40-514, Poland
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Krakow, 31-501, Poland
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Lublin, 20-080, Poland
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Warsaw, 02-034, Poland
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Wroclaw, 50-556, Poland
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Dammam, 31444, Saudi Arabia
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Riyadh, 11426, Saudi Arabia
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NOT_YET_RECRUITING

Riyadh, 11525, Saudi Arabia
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Riyadh, 12713, Saudi Arabia
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NOT_YET_RECRUITING

Banská Bystrica, 974 01, Slovakia
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Bratislava, 833 10, Slovakia
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Košice, 041 91, Slovakia
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Martin, 036 59, Slovakia
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Trnava, 917 75, Slovakia
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Busan, 48108, South Korea
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Gyeonggi-do, 13620, South Korea
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Hwasun-gun, 58128, South Korea
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Seongnam-si, 13496, South Korea
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Seoul, 03080, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 120-752, South Korea
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Barcelona, 08035, Spain
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Madrid, 28007, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Santander, 39008, Spain
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Kaohsiung City, 00807, Taiwan
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Kaohsiung City, 82445, Taiwan
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Kaohsiung City, 833, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 407219, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10400, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 50200, Thailand
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Mueang, 47000, Thailand
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Naimuang, 30000, Thailand
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Ongkharak, 26120, Thailand
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Si Sa Ket, 33000, Thailand
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Altındağ, 06230, Turkey (Türkiye)
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Antalya, 07100, Turkey (Türkiye)
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Istanbul, 34218, Turkey (Türkiye)
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Izmir, 35340, Turkey (Türkiye)
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Mezitli, 33200, Turkey (Türkiye)
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Yakutiye, 25040, Turkey (Türkiye)
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Birmingham, B15 2GW, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Greater London, SW3 6JJ, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, EC1A 7BE, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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NOT_YET_RECRUITING

Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Vinh, 460000, Vietnam

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