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Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
Sponsor: AstraZeneca
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
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
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
Locations (263)
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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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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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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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Naples, Italy
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Padova, 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