Spots Global Cancer Trial Database for Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
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Trial Identification
Brief Title: Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
Official Title: A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)
Study ID: NCT04379596
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Santa Monica, California, United States
Research Site, Westwood, Kansas, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Boston, Massachusetts, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, New York, New York, United States
Research Site, Durham, North Carolina, United States
Research Site, Houston, Texas, United States
Research Site, Fairfax, Virginia, United States
Research Site, Florianopolis, , Brazil
Research Site, Londrina, , Brazil
Research Site, Natal, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Ribeirão Preto, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Santa Maria, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São Jose do Rio Preto, , Brazil
Research Site, São Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Edmonton, Alberta, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Quebec, , Canada
Research Site, Chengdu, , China
Research Site, Guangzhou, , China
Research Site, Guiyang, , China
Research Site, Hangzhou, , China
Research Site, Hefei, , China
Research Site, Hefei, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Urumqi, , China
Research Site, Wuhan, , China
Research Site, Xiamen, , China
Research Site, Zhengzhou, , China
Research Site, Frankfurt, , Germany
Research Site, Frankfurt, , Germany
Research Site, Hamburg, , Germany
Research Site, Leipzig, , Germany
Research Site, Mannheim, , Germany
Research Site, München, , Germany
Research Site, Milano, , Italy
Research Site, Milano, , Italy
Research Site, Napoli, , Italy
Research Site, Padova, , Italy
Research Site, Roma, , Italy
Research Site, Verona, , Italy
Research Site, Chuo-ku, , Japan
Research Site, Kashiwa, , Japan
Research Site, Kita-gun, , Japan
Research Site, Ota-shi, , Japan
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Amsterdam, , Netherlands
Research Site, Amsterdam, , Netherlands
Research Site, Utrecht, , Netherlands
Research Site, Gdańsk, , Poland
Research Site, Konin, , Poland
Research Site, Koszalin, , Poland
Research Site, Kraków, , Poland
Research Site, Lublin, , Poland
Research Site, Opole, , Poland
Research Site, Tomaszów Mazowiecki, , Poland
Research Site, Warszawa, , Poland
Research Site, Kostroma, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Novosibirsk, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, Sankt-Peterburg, , Russian Federation
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Santander, , Spain
Research Site, Sevilla, , Spain
Research Site, Kaohsiung, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan, , Taiwan
Research Site, Cambridge, , United Kingdom
Research Site, Dundee, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Sutton, , United Kingdom
Contact Details
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