Biliary Tract CancerPhase 3DESTINY-BTC01NCT06467357
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
A Phase 3 study testing Gemcitabine, Cisplatin and Durvalumab in people with Biliary Tract Cancer, run by AstraZeneca at 272 sites in 27 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Gemcitabine, Cisplatin and Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 272 sitesin 27 countries
- Study dates
- 12 Aug 2024to 16 May 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
272 sites in 27 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
272 sites in 27 countries
United States50 sites, 32 recruiting
- Withdrawn
Research Site
Albuquerque, New Mexico, 87102
- Recruiting
Research Site
Atlanta, Georgia, 30309
- Withdrawn
Research Site
Austin, Texas, 78705
- Withdrawn
Research Site
Boston, Massachusetts, 02215
- Recruiting
Research Site
Chicago, Illinois, 60612
- Suspended
Research Site
Cleveland, Ohio, 44111
- Recruiting
Research Site
Cleveland, Ohio, 44124
- Recruiting
Research Site
Cleveland, Ohio, 44195
- Withdrawn
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Coeur d'Alene, Idaho, 83814
- Recruiting
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Columbus, Ohio, 43210
- Recruiting
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Dallas, Texas, 75246
- Withdrawn
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Detroit, Michigan, 48202
- Recruiting
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Fairfax, Virginia, 22031
- Withdrawn
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Fairfax, Virginia, 22031
- Recruiting
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Fort Myers, Florida, 33901
- Withdrawn
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Fort Worth, Texas, 76104
- Recruiting
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Fort Worth, Texas, 76104
- Recruiting
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Fullerton, California, 92835
- Recruiting
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Grand Rapids, Michigan, 49503
- Recruiting
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Greenville, South Carolina, 29605
- Recruiting
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Houston, Texas, 77030
- Recruiting
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Jacksonville, Florida, 32224
- Recruiting
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Kansas City, Missouri, 64111
- Recruiting
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Kansas City, Missouri, 64132
- Recruiting
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La Jolla, California, 92093
- Suspended
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Los Alamitos, California, 90720
- Recruiting
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Los Angeles, California, 90017
- Recruiting
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Los Angeles, California, 90089
- Withdrawn
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Nashville, Tennessee, 37203
- Withdrawn
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New York, New York, 10032
- Recruiting
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Niles, Illinois, 60714
- Withdrawn
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Pearland, Texas, 77584
- Not yet recruiting
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Pittsburgh, Pennsylvania, 15232
- Recruiting
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Rochester, Minnesota, 55905
- Withdrawn
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San Antonio, Texas, 78217
- Withdrawn
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San Antonio, Texas, 78258
- Recruiting
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San Francisco, California, 94143
- Recruiting
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Scottsdale, Arizona, 85259
- Recruiting
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St Louis, Missouri, 63110
- Recruiting
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St. Petersburg, Florida, 33705
- Suspended
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Tampa, Florida, 33606
- Recruiting
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Towson, Maryland, 21204
- Withdrawn
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Tucson, Arizona, 85704
- Recruiting
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Tucson, Arizona, 85719
- Withdrawn
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Walnut Creek, California, 94598
- Not yet recruiting
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Washington D.C., District of Columbia, 20007
- Not yet recruiting
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Washington D.C., District of Columbia, 20010
- Recruiting
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West Palm Beach, Florida, 33401
- Recruiting
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White Plains, New York, 10601
- Withdrawn
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Worcester, Massachusetts, 01655
China41 sites, 37 recruiting
- Recruiting
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Beijing, 100020
- Withdrawn
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Beijing, 100021
- Recruiting
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Beijing, 100034
- Recruiting
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Beijing, 100142
- Recruiting
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Beijing
- Recruiting
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Bengbu, 233004
- Recruiting
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Changchun, 130021
- Recruiting
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Changde, 415000
- Recruiting
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Changsha, 410005
- Recruiting
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Changsha, 410013
- Recruiting
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Chengdu, 610041
- Recruiting
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Chengdu, 610078
- Withdrawn
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Chongqing, 400030
- Recruiting
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Fuzhou, 350007
- Recruiting
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Guangzhou, 510080
- Recruiting
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Guangzhou, 510515
- Recruiting
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Guiyang, 550044
- Recruiting
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Hangzhou, 310016
- Terminated
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Harbin, 150081
- Recruiting
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Hefei, 230001
- Recruiting
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Hefei, 230601
- Recruiting
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Jinan, 250117
- Recruiting
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Kunming, 650101
- Recruiting
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Linyi, 276000
- Recruiting
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Luoyang, 471000
- Recruiting
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Nanchang, 330029
- Recruiting
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Nanjing, 2100008
- Recruiting
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Nanning, 530021
- Recruiting
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Nantong, 226001
- Not yet recruiting
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Shanghai, 200001
- Withdrawn
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Shanghai, 201107
- Recruiting
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Shanghai, 201114
- Recruiting
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Shenyang, 110004
- Not yet recruiting
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Shenzhen, 518116
- Recruiting
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Tianjin, 300060
- Recruiting
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Weifang, 261000
- Recruiting
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Wenzhou, 325035
- Recruiting
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Wuhan, 430079
- Recruiting
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Xi'an, 710061
- Recruiting
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Zhengzhou, 450008
- Recruiting
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Zhengzhou, 450052
Japan31 sites, 31 recruiting
- Recruiting
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Bunkyō City, 113-8431
- Recruiting
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Bunkyō City, 113-8603
- Recruiting
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Bunkyō City, 113-8677
- Recruiting
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Chiba, 260-0877
- Recruiting
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Fukuyama-shi, 721-8511
- Recruiting
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Hirakata-shi, 573-1191
- Recruiting
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Hiroshima, 734-8551
- Recruiting
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Kanazawa, 920-8641
- Recruiting
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Kashiwa, 227-8577
- Recruiting
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Kawasaki-shi, 216-8511
- Recruiting
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Kita-gun, 761-0793
- Recruiting
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Kitaadachi-gun, 362-0806
- Recruiting
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Kōtoku, 135-8550
- Recruiting
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Kumamoto, 860-8556
- Not yet recruiting
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Kurashiki-shi, 710-8602
- Recruiting
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Kyoto, 606-8507
- Recruiting
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Maebashi, 371-8511
- Recruiting
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Mitaka-shi, 181-8611
- Recruiting
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Nagoya, 464-8681
- Recruiting
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Nagoya, 466-8560
- Recruiting
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Osaka, 541-8567
- Recruiting
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Osaka, 545-8586
- Recruiting
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Sakaishi, 591-8025
- Recruiting
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Sapporo, 060-8543
- Recruiting
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Sendai, 980-8574
- Recruiting
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Shinjuku-ku, 160-8582
- Recruiting
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Suita, 565-0871
- Recruiting
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Sunto-gun, 411-8777
- Recruiting
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Ube-shi, 755-8505
- Recruiting
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Wakayama, 641-8510
- Recruiting
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Yokohama, 241-8515
Germany13 sites, 13 recruiting
- Recruiting
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Berlin, 13353
- Recruiting
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Bonn, 53127
- Recruiting
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Cologne, 50937
- Recruiting
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Dresden, 01370
- Recruiting
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Frankfurt, 60488
- Recruiting
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Freiburg im Breisgau, 79106
- Recruiting
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Göttingen, 37075
- Recruiting
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Hamburg, 22763
- Recruiting
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Leipzig, 4103
- Recruiting
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Lübeck, 23538
- Recruiting
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München, 81377, DE
- Recruiting
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Ulm, 89081
- Recruiting
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Würzburg, 97080
France10 sites, 10 recruiting
- Recruiting
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Brest, 29609
- Recruiting
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Clichy, 92118
- Not yet recruiting
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Dijon, 21079
- Recruiting
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Lille, 59037
- Recruiting
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Lyon, 69008
- Recruiting
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Lyon, 69373
- Recruiting
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Marseille, 13008
- Recruiting
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Montpellier, 34295
- Recruiting
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Pessac, 33604
- Recruiting
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Villejuif, 94800
India9 sites, 6 recruiting
- Recruiting
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Dehradun, 248016
- Recruiting
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Delhi, 110029
- Recruiting
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Delhi, 110088
- Withdrawn
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Kanpur, 208001
- Withdrawn
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Kolkata, 700054
- Recruiting
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Kolkata, 700094
- Recruiting
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Mumbai, 400012
- Recruiting
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Vadodara, 391760
- Withdrawn
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Varanasi, 221005
Italy9 sites, 9 recruiting
- Recruiting
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Florence, 50134
- Recruiting
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Milan, 20132
- Recruiting
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Milan, 20162
- Recruiting
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Naples, 80128
- Recruiting
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Naples, 80131
- Recruiting
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Padova, 35128
- Recruiting
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Roma, 00133
- Recruiting
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Rozzano, 20089
- Recruiting
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Tricase, 73039
South Korea9 sites, 9 recruiting
- Recruiting
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Busan, 48108
- Recruiting
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Gyeonggi-do, 13620
- Recruiting
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Hwasun-gun, 58128
- Recruiting
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Seongnam-si, 13496
- Recruiting
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Seoul, 03080
- Recruiting
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Seoul, 05505
- Recruiting
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Seoul, 06351
- Recruiting
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Seoul, 06591
- Recruiting
Research Site
Seoul, 120-752
Taiwan8 sites, 8 recruiting
- Recruiting
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Kaohsiung City, 00807
- Recruiting
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Kaohsiung City, 82445
- Recruiting
Research Site
Kaohsiung City, 833
- Recruiting
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Taichung, 40447
- Recruiting
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Taichung, 407219
- Recruiting
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Taipei, 10002
- Recruiting
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Taipei, 112
- Recruiting
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Taoyuan, 333
Thailand8 sites, 8 recruiting
- Recruiting
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Bangkok, 10400
- Recruiting
Research Site
Hat Yai, 90110
- Recruiting
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Khon Kaen, 40002
- Recruiting
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Muang, 50200
- Recruiting
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Mueang, 47000
- Recruiting
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Naimuang, 30000
- Recruiting
Research Site
Ongkharak, 26120
- Recruiting
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Si Sa Ket, 33000
Brazil7 sites, 7 recruiting
- Recruiting
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Natal, 59012-300
- Recruiting
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Porto Alegre, 90035-000
- Recruiting
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Porto Alegre, 91350-200
- Recruiting
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Santa Maria, 97015-450
- Recruiting
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São Paulo, 01246-000
- Recruiting
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São Paulo, 05651-901
- Recruiting
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Vitória, 29043-272
Vietnam7 sites, 6 recruiting
- Not yet recruiting
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Da Nang, 550000
- Recruiting
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Hanoi, 100000
- Recruiting
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Ho Chi Minh City, 700000
- Withdrawn
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Ho Chi Minh City, 700000
- Not yet recruiting
Research Site
Ho Chi Minh City, 700000
- Recruiting
Research Site
Ho Chi Minh City, 70000
- Recruiting
Research Site
Vinh, 460000
Belgium6 sites, 6 recruiting
- Recruiting
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Anderlecht, 1070
- Recruiting
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Edegem, 2650
- Recruiting
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Ghent, 9000
- Recruiting
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Leuven, 3000
- Recruiting
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Liège, 4000
- Recruiting
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Roeselare, 8800
Czechia6 sites, 5 recruiting
- Withdrawn
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Brno, 625 00
- Recruiting
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Brno, 656 53
- Recruiting
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Hradec Králové, 500 05
- Recruiting
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Olomouc, 77900
- Recruiting
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Prague, 100 34
- Recruiting
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Prague, 15006
Poland6 sites, 5 recruiting
- Recruiting
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Bialystok, 15-027
- Recruiting
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Katowice, 40-514
- Recruiting
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Krakow, 31-501
- Recruiting
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Lublin, 20-080
- Recruiting
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Warsaw, 02-034
- Withdrawn
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Wroclaw, 50-556
Spain6 sites, 6 recruiting
- Recruiting
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Barcelona, 08035
- Recruiting
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Madrid, 28007
- Recruiting
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Madrid, 28040
- Recruiting
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Madrid, 28041
- Recruiting
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Málaga, 29010
- Recruiting
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Santander, 39008
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
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Altındağ, 06230
- Recruiting
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Antalya, 07100
- Recruiting
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Istanbul, 34218
- Recruiting
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Izmir, 35340
- Recruiting
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Mezitli, 33200
- Recruiting
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Yakutiye, 25040
United Kingdom6 sites, 6 recruiting
- Recruiting
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Birmingham, B15 2GW
- Recruiting
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Dundee, DD1 9SY
- Recruiting
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Glasgow, G12 0YN
- Recruiting
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Greater London, SW3 6JJ
- Recruiting
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Leeds, LS9 7TF
- Recruiting
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London, EC1A 7BE
Austria5 sites, 5 recruiting
- Recruiting
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Graz, 8036
- Recruiting
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Linz, 4010
- Recruiting
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Salzburg, 5020
- Recruiting
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Vienna, 1090
- Not yet recruiting
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Wiener Neustadt, 2700
Canada5 sites, 5 recruiting
- Recruiting
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Brampton, Ontario, L6R 3J7
- Recruiting
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Edmonton, Alberta, T6G 1Z2
- Recruiting
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Halifax, Nova Scotia, B3H 1V7
- Recruiting
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Montreal, Quebec, H3A 1A1
- Recruiting
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Toronto, Ontario, M5G 2M9
Malaysia5 sites, 5 recruiting
- Recruiting
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George Town, 10990
- Recruiting
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Johor Bahru, 81100
- Recruiting
Research Site
Kuala Lumpur, 50586
- Recruiting
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Kuala Lumpur, 59100
- Recruiting
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Kuching, 93586
Slovakia5 sites, 5 recruiting
- Recruiting
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Banská Bystrica, 974 01
- Recruiting
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Bratislava, 833 10
- Recruiting
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Košice, 041 91
- Recruiting
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Martin, 036 59
- Recruiting
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Trnava, 917 75
Australia4 sites, 4 recruiting
- Recruiting
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Chermside, 4032
- Recruiting
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Clayton, 3168
- Recruiting
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Concord, 2139
- Recruiting
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Nedlands, 6009
Philippines4 sites, 4 recruiting
- Recruiting
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Cebu City, 6000
- Recruiting
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Makati, 1229
- Recruiting
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Pasig, 1605
- Recruiting
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Quezon City, 1112
Saudi Arabia4 sites, 4 recruiting
- Recruiting
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Dammam, 31444
- Recruiting
Research Site
Riyadh, 11426
- Not yet recruiting
Research Site
Riyadh, 11525
- Recruiting
Research Site
Riyadh, 12713
About this study
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
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.
- Conditions
- Biliary Tract Cancer
- Being tested
- Gemcitabine, Cisplatin, Durvalumab, Trastuzumab deruxtecan, Rilvegostomig
- Keywords
- Biliary Tract Cancer, HER2, HER2 expressing BTC, Trastuzumab deruxtecan, T-DXd, Rilvegostomig
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Standard of care chemotherapy by intravenous infusion
CisplatinDrug
Standard of care chemotherapy by intravenous infusion
DurvalumabDrug
Standard of care immunotherapy by intravenous infusion
Trastuzumab deruxtecanDrug
Also called DS-8201a; T-DXd
Experimental therapy by intravenous infusion
RilvegostomigDrug
Experimental therapy by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab deruxtecan + rilvegostomig | Experimental | Trastuzumab deruxtecan (T-DXd; DS-8201a) in combination with rilvegostomig arm Receives: Drug: Trastuzumab deruxtecan; Drug: Rilvegostomig |
| Trastuzumab deruxtecan | Experimental | Trastuzumab deruxtecan (T-DXd; DS-8201a) arm Receives: Drug: Trastuzumab deruxtecan |
| Standard of Care | Active comparator | Gemcitabine and cisplatin in combination with durvalumab arm Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig
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.
Measured: Until all patients have completed at least 1 full Cycle (each cycle is 21 days)
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+) population
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.
Measured: From date of treatment randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
Secondary outcomes (27)
To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population
Overall Survival (OS) in FAS (HER2 IHC 3+/2+) population. OS definition as above.
Measured: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population
Overall Survival (OS) in FAS (HER2 IHC 3+) population. OS definition as above.
Measured: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population
Overall Survival (OS) in FAS (HER2 IHC 3+/2+) population. OS definition as above.
Measured: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
To further evaluate efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression.
The measure of interest is the hazard ratio of PFS.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To further evaluate efficacy of T-DXd monotherapy vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression.
The measure of interest is the hazard ratio of PFS.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To further evaluate the efficacy of T-DXd with rilvegostomig vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression.
Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation.
The measure of interest is the risk difference of ORR.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To further evaluate the efficacy of T-DXd monotherapy vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression.
Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation.
The measure of interest is the risk difference of ORR.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To further evaluate efficacy of T-DXd with rilvegostomig vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression.
The measure of interest is the median DoR.
Measured: From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)
To further evaluate efficacy of T-DXd monotherapy vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression.
The measure of interest is the median DoR.
Measured: From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months)
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Overall survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
Overall survival (OS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
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.
Measured: From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized)
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of PFS in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression.
The measure of interest is the hazard ratio of PFS.
Measured: From the date of randomisation until progression or death due to any cause, whichever occurs first (estimated up to 50 months)
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Duration of response in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression.
The measure of interest is the median DoR.
Measured: From the date of first response until progression or death due to any cause, whichever occurs first (estimated up to 50 months)
To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Objective response rate in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations
Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.
ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression.
Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation.
The measure of interest is the risk difference of ORR.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To assess the safety and tolerability of T-DXd with rilvegostomig vs Standard of Care
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.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To assess the safety and tolerability of T-DXd monotherapy vs Standard of Care
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.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on a summary of symptomatic AEs
Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322).
Measured: Until End of Study (estimated up to 50 months)
To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on a summary of symptomatic AEs
Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322)
Measured: Until End of Study (estimated up to 50 months)
To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to T-DXd monotherapy based on a summary of symptomatic AEs
Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322).
Measured: Until End of Study (estimated up to 50 months)
To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs Standard of Care
Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration.
Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold.
- The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized.
Measured: Until End of Study (estimated up to 50 months)
To assess time to deterioration in physical functioning in patients treated with T-DXd monotherapy vs Standard of care
Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration.
Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold.
- The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized.
Measured: Until End of Study (estimated up to 50 months)
To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs T-DXd monotherapy
Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration.
Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold.
- The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized.
Measured: Until End of Study (estimated up to 50 months)
To assess the pharmacokinetics of T-DXd, total anti- HER2 antibody, DXd and rilvegostomig in serum
Descriptive analysis of serum concentration of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig in all applicable arms.
Measured: From the time of informed consent until 90 days after the last dose of T-DXd and rilvegostomig
To investigate the immunogenicity of T-DXd and of rilvegostomig
Descriptive summary of presence of ADAs for T-DXd and rilvegostomig in all applicable arms.
Measured: From the time of informed consent until 30 and 90 days after the last dose of T-DXd and rilvegostomig, respectively
To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on overall side-effect bother
Patient-reported tolerability will be described using the Overall side-effect bother that will be mesured using PGI-TT
Measured: Until End of Study (estimated up to 50 months)
To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on overall side-effect bother
Patient-reported tolerability will be described using the Overall side-effect bother that will be assessed will be mesured using PGI-TT
Measured: Until End of Study (estimated up to 50 months)
To assess the safety and tolerability of T-DXd with rilvegostomig vs T-DXd monotherapy
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.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months)
To describe patient-reported tolerability of T-DXd with rilvegostmog in comparison to T-DXd monotherapy based on overall side-effect bother
Patient-reported tolerability will be described using the Overall side-effect bother that will be assessed will be mesured using PGI-TT.
Measured: Until End of Study (estimated up to 50 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start12 Aug 2024
- Primary completion12 Jun 2028 (estimated)
- Study completion16 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467357
- Sponsor's protocol ID
- D781PC00001
- Other IDs
- 2023-508057-19-00, 2023
- Acronym
- DESTINY-BTC01
- Status last verified
- Oct 2026
- First submitted
- 21 May 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.