Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
NCT ID: NCT06467357
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
620 participants
INTERVENTIONAL
2024-08-12
2029-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trastuzumab deruxtecan + rilvegostomig
Trastuzumab deruxtecan (T-DXd; DS-8201a) in combination with rilvegostomig arm
Trastuzumab deruxtecan
Experimental therapy by intravenous infusion
Rilvegostomig
Experimental therapy by intravenous infusion
Trastuzumab deruxtecan
Trastuzumab deruxtecan (T-DXd; DS-8201a) arm
Trastuzumab deruxtecan
Experimental therapy by intravenous infusion
Standard of Care
Gemcitabine and cisplatin in combination with durvalumab arm
Gemcitabine
Standard of care chemotherapy by intravenous infusion
Cisplatin
Standard of care chemotherapy by intravenous infusion
Durvalumab
Standard of care immunotherapy by intravenous infusion
Interventions
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Gemcitabine
Standard of care chemotherapy by intravenous infusion
Cisplatin
Standard of care chemotherapy by intravenous infusion
Durvalumab
Standard of care immunotherapy by intravenous infusion
Trastuzumab deruxtecan
Experimental therapy by intravenous infusion
Rilvegostomig
Experimental therapy by intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is \> 3 months (90 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.
* Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.
* Patients must provide an FFPE tumor sample that is no older than 3 years for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 status, and other correlatives.
* Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (Randomized portion only)
* WHO/ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
* Adequate organ and bone marrow function within 14 days before randomization.
* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.
* Minimum life expectancy of 12 weeks.
Exclusion Criteria
* 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.
18 Years
99 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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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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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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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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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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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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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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
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München, , Germany
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Ulm, , Germany
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Würzburg, , Germany
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Hong Kong, , Hong Kong
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Shatin, , Hong Kong
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Dehradun, , India
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Delhi, , India
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Delhi, , India
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Kanpur, , India
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Kolkata, , India
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Kolkata, , India
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Mumbai, , India
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Vadodara, , India
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Varanasi, , India
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Florence, , Italy
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Milan, , Italy
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Milan, , Italy
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Naples, , Italy
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Napoli, , Italy
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Padua, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Tricase, , Italy
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Bunkyō City, , Japan
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Bunkyō City, , Japan
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Bunkyō City, , Japan
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Chiba, , Japan
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Fukuyama-shi, , Japan
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Hirakata-shi, , Japan
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Hiroshima, , Japan
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Kanazawa, , Japan
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Kashiwa, , Japan
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Kawasaki-shi, , Japan
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Kita-gun, , Japan
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Kitaadachi-gun, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Kyoto, , Japan
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Maebashi, , Japan
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Mitaka-shi, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Sakaishi, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Suita, , Japan
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Sunto-gun, , Japan
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Ube-shi, , Japan
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Wakayama, , Japan
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Yokohama, , Japan
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George Town, , Malaysia
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Johor Bahru, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuching, , Malaysia
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Rotterdam, , Netherlands
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Cebu City, , Philippines
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Makati, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Bialystok, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Dammam, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Martin, , Slovakia
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Trnava, , Slovakia
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Busan, , South Korea
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Gyeonggi-do, , South Korea
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Hwasun-gun, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Santander, , Spain
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Muang, , Thailand
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Mueang, , Thailand
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Naimuang, , Thailand
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Ongkharak, , Thailand
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Si Sa Ket, , Thailand
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Altındağ, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Mezitli, , Turkey (Türkiye)
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Yakutiye, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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Dundee, , United Kingdom
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Glasgow, , United Kingdom
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Greater London, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Vinh, , Vietnam
Countries
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Central Contacts
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Other Identifiers
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2023-508057-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D781PC00001
Identifier Type: -
Identifier Source: org_study_id
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