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RECRUITING

NCT06467357

PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

620

Start Date

2024-08-12

Completion Date

2029-05-16

Last Updated

2026-10-13

Healthy Volunteers

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

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 (or surgery or radiation with curative intent) 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. * 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, cardiomyopathy of any etiology, history of myocarditis, clinically important cardiac arrhythmias, or a recent (\< 6 months) cardiovascular event including stroke. * 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). * Active primary immunodeficiency and/or active uncontrolled infectious disease(s). * 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.

Locations (272)

Research Site

Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Fullerton, California, United States

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La Jolla, California, United States

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Los Alamitos, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Walnut Creek, California, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Chicago, Illinois, United States

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Niles, Illinois, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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White Plains, New York, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Greenville, South Carolina, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Pearland, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Fairfax, Virginia, United States

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Fairfax, Virginia, United States

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Chermside, Australia

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Clayton, Australia

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Concord, Australia

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Nedlands, Australia

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Graz, Austria

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Linz, Austria

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Salzburg, Austria

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Vienna, Austria

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Wiener Neustadt, Austria

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Anderlecht, Belgium

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Edegem, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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Roeselare, Belgium

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Natal, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Santa Maria, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Vitória, Brazil

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Edmonton, Alberta, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Beijing, China

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Beijing, China

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Beijing, China

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Beijing, China

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Beijing, China

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Bengbu, China

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Changchun, China

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Changde, China

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Changsha, China

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Changsha, China

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Chengdu, China

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Chengdu, China

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Chongqing, China

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Fuzhou, China

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Guangzhou, China

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Guangzhou, China

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Guiyang, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Hefei, China

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Jinan, China

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Kunming, China

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Linyi, China

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Luoyang, China

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Nanchang, China

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Nanjing, China

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Nanning, China

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Nantong, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Shenzhen, China

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Tianjin, China

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Weifang, China

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Wenzhou, China

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Wuhan, China

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Xi'an, China

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Zhengzhou, China

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Zhengzhou, China

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Brno, Czechia

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Brno, Czechia

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Hradec Králové, Czechia

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Olomouc, Czechia

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Prague, Czechia

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Prague, Czechia

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Brest, France

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Clichy, France

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Dijon, France

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Lille, France

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Lyon, France

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Lyon, France

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Marseille, France

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Montpellier, France

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Pessac, France

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Villejuif, France

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Berlin, Germany

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Bonn, Germany

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Cologne, Germany

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Dresden, Germany

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Frankfurt, Germany

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Freiburg im Breisgau, Germany

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Göttingen, Germany

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Hamburg, Germany

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Leipzig, Germany

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Lübeck, Germany

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (272)