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NCT07851025PHASE3Recruiting

Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer

AstraZeneca

Start Date

9/16/2026

Completion Date

8/17/2033

Summary

This study will evaluate the efficacy, safety and tolerability of Torvutatug samrotecan (torvu-sam) in combination with bevacizumab compared with bevacizumab monotherapy as first line maintenance treatment in patients with Homologous Recombination Deficient (HRD) negative advanced ovarian cancer.

Detailed Description

This study aims to see if torvu-sam in combination with bevacizumab allows patients to live longer without the cancer getting worse, compared to patients receiving bevacizumab. Eligible patients will be those patients who have not progressed following completion of first line induction treatment with Platinum-based chemotherapy (PBC) and bevacizumab. All patients must be HRD-negative through pre-existing study approved local test or prospective central test and have a confirmed folate receptor alpha status determined by prospective central test.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Participants with newly diagnosed FIGO Stage III/IV, histologically confirmed epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma * Provision of an archival FFPE tumour sample * Participants who have completed at least 6 cycles and a maximum of 8 cycles of first-line Platinum-based chemotherapy (PBC) prior to randomisation * Participants must have received a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of PBC, prior to randomisation * Participants who have completed cytoreductive surgery or have inoperable disease * Participants with non-progressive disease upon completion of front-line induction therapy * HRD negative tumour Key Exclusion Criteria: * Participants with tumours of non-epithelial origin, borderline tumours, or low-grade epithelial tumours. * Participants with history of (non-infectious) ILD/pneumonitis that required steroids or supplemental oxygen, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening * Participants with non-healing wound, active ulcer, or bone fracture * Participants with evidence of active or ongoing bowel obstruction * Prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)

Interventions

DRUG

Torvutatug samrotecan

DRUG

Bevacizumab

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Conditions

Epithelial Ovarian Cancer

Locations

Research Site

Tampa, Florida 33606

United States

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Baltimore, Maryland 21201

United States

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Billings, Montana 59106

United States

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Cleveland, Ohio 44195

United States

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Buenos Aires, C1122AAL

Argentina

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Buenos Aires, C1125ABD

Argentina

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Capital Federal, 1118

Argentina

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Ciudad de Buenos Aires, 1015

Argentina

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Ciudad de Buenos Aires, 1426

Argentina

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Córdoba, X5000AAW

Argentina

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Córdoba, X5000HXK

Argentina

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Córdoba, X5008HHW

Argentina

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Rosario, S2000KZE

Argentina

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Salta, A4400EMI

Argentina

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Santa Fe, S2002RE

Argentina

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Viedma, R8500ACE

Argentina

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Auchenflower, 4066

Australia

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Benowa, 4217

Australia

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Hobart, 7000

Australia

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Kingswood, 2747

Australia

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Nedlands, 6009

Australia

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Port Macquarie, 2444

Australia

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Randwick, 2031

Australia

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Richmond, 3121

Australia

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Toorak Gardens, 5065

Australia

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Wollongong, 2500

Australia

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Fortaleza, 60336-045

Brazil

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Itajaí, 88301-220

Brazil

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Jaú, 17210-080

Brazil

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Natal, 59075-740

Brazil

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Porto Alegre, 90020-090

Brazil

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Rio de Janeiro, 20230-130

Brazil

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Salvador, 41253-190

Brazil

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São Paulo, 01317-000

Brazil

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São Paulo, 01409-902

Brazil

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São Paulo, 04014-002

Brazil

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Dobrich, 9300

Bulgaria

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Plovdiv, 4000

Bulgaria

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Shumen, 9700

Bulgaria

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Sofia, 1330

Bulgaria

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Sofia, 1407

Bulgaria

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Sofia, 1797

Bulgaria

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Toronto, Ontario M5G 2M9

Canada

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Montreal, Quebec H4A 3J1

Canada

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Santiago, 7520426

Chile

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Santiago,

Chile

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Temuco, 4780000

Chile

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Viña del Mar, 2540364

Chile

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Beijing, 100034

China

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Beijing, 100036

China

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Beijing, 100210

China

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Beijing, 100730

China

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Binzhou Shi, 256603

China

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Changchun, 130021

China

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Changsha, 410013

China

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Chengdu, 610072

China

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Chongqing, 400030

China

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Fuzhou, 350014

China

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Guangzhou, 510080

China

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Haikou, 570311

China

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Hangzhou, 310003

China

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Hangzhou, 310022

China

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Hangzhou, 310052

China

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Hefei, 230031

China

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Huangpu District, 200025

China

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Jinan, 250021

China

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Jinan, 250117

China

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Linyi, 276001

China

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Luzhou, 646000

China

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Nanchang, 330006

China

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Nanjing, 210000

China

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Nanjing, 210009

China

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Neijiang, 641000

China

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Shanghai, 200011

China

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Shanghai, 200032

China

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Shenzhen, 518039

China

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Shijiazhuang, 050000

China

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Suzhou, 215004

China

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Taiyuan, 030013

China

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Weifang, 261000

China

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Wenzhou, 325015

China

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Wuhan, 430060

China

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Xinxiang, 453100

China

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Xuzhou, 221009

China

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Bogotá, 110221

Colombia

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Bogotá,

Colombia

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Medellín, 50018

Colombia

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Pasto, 520002

Colombia

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Berlin, 13353

Germany

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Bonn, 53127

Germany

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Hanover, 30625

Germany

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Wiesbaden, 65199

Germany

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Athens, 11528

Greece

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Pátrai, 26332

Greece

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Ansārinagar, 110 029

India

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Bhubaneswar, 751007

India

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Hyderabad, 500004

India

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Mumbai, 400012

India

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Mumbai, 400016

India

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Nagpur, 440001

India

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Nashik, 422 009

India

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New Delhi, 110 085

India

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Pune, 411004

India

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Thiruvananthapuram, 695011

India

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Hadera, 38100

Israel

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Haifa, 31096

Israel

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Haifa, 34362

Israel

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Holon, 5822012

Israel

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Jerusalem, 9103102

Israel

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Kfar Saba, 44281

Israel

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Nahariya, 22100

Israel

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Tel Aviv, 6423906

Israel

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Florence, 50134

Italy

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Genova, 16132

Italy

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Fukushima, 960-1295

Japan

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Ginowan-shi, 901-2725

Japan

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Hidaka-shi, 350-1298

Japan

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Isehara-shi, 259-1193

Japan

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Kashiwa-shi, 277-8567

Japan

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Kawasaki-shi, 216-8511

Japan

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Kobe, 650-0047

Japan

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Kōtoku, 135-8550

Japan

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Kurume-shi, 830-0011

Japan

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Kyoto, 612-8555

Japan

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Minatoku, 105-8471

Japan

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Nagoya, 464-8681

Japan

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Nagoya, 466-8560

Japan

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Niigata, 951-8520

Japan

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Osaka, 541-8567

Japan

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Osaka, 545-8586

Japan

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Ota-shi, 373-8550

Japan

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Sagamihara-shi, 252-0375

Japan

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Sapporo, 003-0804

Japan

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Sapporo, 060-8543

Japan

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Sendai, 980-8574

Japan

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Shinjuku-ku, 160-8582

Japan

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Shiwa-gun, 028-3695

Japan

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Suita, 565-0871

Japan

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Sunto-gun, 411-8777

Japan

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Toon-Shi, 791-0295

Japan

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Tsu, 514-8507

Japan

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Yokohama, 236-0004

Japan

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Yokohama, 241-8515

Japan

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Kuala Lumpur, 59100

Malaysia

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Kuala Selangor, 46050

Malaysia

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Kuala Selangor, 62250

Malaysia

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Petaling Jaya, 46300

Malaysia

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Arequipa, AREQUIPA01

Peru

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Lima, 15036

Peru

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Lima, 15038

Peru

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Lima, LIMA 32

Peru

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Wanchac, 8002

Peru

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Cebu, 6000

Philippines

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City of Muntinlupa, 1780

Philippines

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Quezon, 1102

Philippines

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Trenčín, 81171

Slovakia

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Ljubljana, 1000

Slovenia

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Busan, 49241

South Korea

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Daegu, 42601

South Korea

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Goyang-si, 10408

South Korea

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Gyeonggi-do, 13620

South Korea

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Seongnam-si, 13496

South Korea

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Seoul, 03080

South Korea

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Seoul, 03722

South Korea

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Seoul, 06273

South Korea

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Seoul, 06351

South Korea

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Seoul, 06591

South Korea

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Seoul, 5505

South Korea

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Yangsan, 50612

South Korea

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Barcelona, 08003

Spain

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Barcelona, 08025

Spain

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Kaohsiung City, 81362

Taiwan

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Kaohsiung City, 833401

Taiwan

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New Taipei City, 220

Taiwan

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Taichung, 40447

Taiwan

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Taichung, 40705

Taiwan

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Tainan, 70403

Taiwan

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Tainan, 73657

Taiwan

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Taipei, 100

Taiwan

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Taipei, 10449

Taiwan

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Taipei, 11217

Taiwan

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Taipei, 11259

Taiwan

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Taoyuan, 333

Taiwan

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Bangkok, 10210

Thailand

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Bangkok, 10300

Thailand

Research Site

Bangkok, 10330

Thailand