Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
Start Date
6/3/2020
Completion Date
6/1/2027
Summary
DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients. Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.
Eligibility Criteria
Age Range: 18 years to 130 years
Interventions
Fluorouracil (5-FU)
Capecitabine
Durvalumab
Oxaliplatin
Trastuzumab
Trastuzumab deruxtecan
Cisplatin
Pembrolizumab
Volrustomig
Rilvegostomig
Conditions
Locations
Research Site
Santa Monica, California 90404
United States
Research Site
Westwood, Kansas 66205
United States
Research Site
Baltimore, Maryland 21287
United States
Research Site
Boston, Massachusetts 02114
United States
Research Site
Boston, Massachusetts 02215
United States
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Ann Arbor, Michigan 48109
United States
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New York, New York 10065
United States
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Durham, North Carolina 27710
United States
Research Site
Houston, Texas 77090
United States
Research Site
Fairfax, Virginia 22031
United States
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Florianópolis, 88020-210
Brazil
Research Site
Londrina, 86015-520
Brazil
Research Site
Natal, 59075-740
Brazil
Research Site
Porto Alegre, 90160-093
Brazil
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Ribeirão Preto, 14051-140
Brazil
Research Site
Rio de Janeiro, 22793-080
Brazil
Research Site
Santa Maria, 97015-450
Brazil
Research Site
São Jose Do Rio Preto, 15090-000
Brazil
Research Site
São Paulo, 01509-900
Brazil
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São Paulo, 03102-002
Brazil
Research Site
São Paulo, 045202-001
Brazil
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Edmonton, Alberta T6G 1Z2
Canada
Research Site
Ottawa, Ontario K1H 8L6
Canada
Research Site
Toronto, Ontario M4N 3M5
Canada
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Toronto, Ontario M5G 2M9
Canada
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Montreal, Quebec H4A 3J1
Canada
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Québec, Quebec G1J 1Z4
Canada
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Chengdu, 610042
China
Research Site
Guangzhou, 510062
China
Research Site
Guiyang, 550002
China
Research Site
Hangzhou, 310022
China
Research Site
Hefei, 230001
China
Research Site
Hefei, 230601
China
Research Site
Shanghai, 200025
China
Research Site
Shanghai, 200031
China
Research Site
Shanghai, 200032
China
Research Site
Shanghai, 200050
China
Research Site
Shenyang, 110001
China
Research Site
Ürümqi, 830000
China
Research Site
Wuhan, 430000
China
Research Site
Xiamen, 361003
China
Research Site
Zhengzhou, 450008
China
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Frankfurt, 60488
Germany
Research Site
Frankfurt, 60590
Germany
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Hamburg, 20249
Germany
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Leipzig, 04103
Germany
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Mannheim, 68167
Germany
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München, 81675
Germany
Research Site
Milan, 20133
Italy
Research Site
Milan, 20162
Italy
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Naples, 80131
Italy
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Padova, 35128
Italy
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Roma, 00168
Italy
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Verona, 37134
Italy
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Chūōku, 104-0045
Japan
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Kashiwa, 277-8577
Japan
Research Site
Kita-gun, 761-0793
Japan
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Ota-shi, 373-8550
Japan
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Amsterdam, 1066CX
Netherlands
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Amsterdam, 1081 HV
Netherlands
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Utrecht, 3584CG
Netherlands
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Gdansk, 80-214
Poland
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Konin, 62-500
Poland
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Koszalin, 75-581
Poland
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Krakow, 31-501
Poland
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Lublin, 20-090
Poland
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Opole, 45-061
Poland
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Tomaszów Mazowiecki, 97-200
Poland
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Warsaw, 02-034
Poland
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Kostroma, 156005
Russia
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Moscow, 115478
Russia
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Moscow, 125284
Russia
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Moscow, 143423
Russia
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Moscow, 143442
Russia
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Novosibirsk, 630099
Russia
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Saint Petersburg, 195271
Russia
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Saint Petersburg, 196603
Russia
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Saint Petersburg, 197022
Russia
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Saint Petersburg, 197758
Russia
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Seongnam-si, 13620
South Korea
Research Site
Seoul, 03080
South Korea
Research Site
Seoul, 03722
South Korea
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Seoul, 05505
South Korea
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Seoul, 06351
South Korea
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Barcelona, 08035
Spain
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Madrid, 28007
Spain
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Madrid, 28034
Spain
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Santander, 39008
Spain
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Seville, 41013
Spain
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Kaohsiung City, 80756
Taiwan
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Kaohsiung City, 83301
Taiwan
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Tainan, 704
Taiwan
Research Site
Taipei, 10002
Taiwan
Research Site
Taipei, 11217
Taiwan
Research Site
Taoyuan, 333
Taiwan
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Cambridge, CB2 0QQ
United Kingdom
Research Site
Dundee, DD1 9SY
United Kingdom
Research Site
London, NW1 2PG
United Kingdom
Research Site
Manchester, M20 4BX
United Kingdom
Research Site
Sutton, SM2 5PT
United Kingdom