Clinical Research Directory
Browse clinical research sites, groups, and studies.
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
Sponsor: AstraZeneca
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.
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)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2020-06-03
Completion Date
2027-06-01
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
Capecitabine
Capecitabine: administered orally
Durvalumab
Durvalumab: administered as an IV infusion
Oxaliplatin
Oxaliplatin: administered as an IV infusion
Trastuzumab
Trastuzumab: administered as an IV infusion
Trastuzumab deruxtecan
T-DXd: administered as an IV infusion
Cisplatin
Cisplatin: administered as an IV infusion
Pembrolizumab
Pembrolizumab: administered as an IV infusion
Volrustomig
Volrustomig: administered as an IV infusion
Rilvegostomig
Rilvegostomig: administered as an IV infusion
Locations (100)
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
Florianópolis, 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
São Jose Do Rio Preto, Brazil
Research Site
São Paulo, 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
Québec, 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
Shanghai, China
Research Site
Shenyang, China
Research Site
Ürümqi, 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
Milan, Italy
Research Site
Milan, Italy
Research Site
Naples, Italy
Research Site
Padova, Italy
Research Site
Roma, Italy
Research Site
Verona, Italy
Research Site
Chūōku, Japan
Research Site
Kashiwa, Japan
Research Site
Kita-gun, Japan
Research Site
Ota-shi, Japan
Research Site
Amsterdam, Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Utrecht, Netherlands
Research Site
Gdansk, Poland
Research Site
Konin, Poland
Research Site
Koszalin, Poland
Research Site
Krakow, Poland
Research Site
Lublin, Poland
Research Site
Opole, Poland
Research Site
Tomaszów Mazowiecki, Poland
Research Site
Warsaw, Poland
Research Site
Kostroma, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Novosibirsk, Russia
Research Site
Saint Petersburg, Russia
Research Site
Saint Petersburg, Russia
Research Site
Saint Petersburg, Russia
Research Site
Saint Petersburg, Russia
Research Site
Seongnam-si, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Santander, Spain
Research Site
Seville, Spain
Research Site
Kaohsiung City, Taiwan
Research Site
Kaohsiung City, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan District, 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