Esophageal Cancer Clinical Trial
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2+ Gastric Cancer (DESTINY-Gastric03)
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-positive 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-positive 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.
Male and female participants must be at least 18 years of age
Locally advanced, unresectable, or metastatic disease Pathologically documented adenocarcinoma of the stomach, GEJ or esophagus with HER2 overexpression (IHC 3+ or IHC 2+/ISH+)
For Part 1, progression on or after at least one prior trastuzumab containing Regimen.
For Part 2, previously untreated for unresectable or metastatic adenocarcinoma of the stomach, GEJ or esophagus with HER2 overexpression.
Has measurable target disease assessed by the Investigator based on RECIST version 1.1
Has protocol defined adequate organ function including cardiac, renal and hepatic function
If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study.
History of active primary immunodeficiency, known HIV, active HBV or HCV infection.
Uncontrolled intercurrent illness
History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
Lung-specific intercurrent clinically significant severe illnesses.
Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
Has spinal cord compression or clinically active central nervous system metastases.
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There are 93 Locations for this study
Santa Monica California, 90404, United States
Westwood Kansas, 66205, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Houston Texas, 77090, United States
Fairfax Virginia, 22031, United States
Florianopolis , 88020, Brazil
Londrina , 86015, Brazil
Natal , 59075, Brazil
Porto Alegre , 90160, Brazil
Ribeirão Preto , 14051, Brazil
Rio de Janeiro , 22793, Brazil
Santa Maria , 97015, Brazil
Sao Paulo , 01509, Brazil
São Jose do Rio Preto , 15090, Brazil
São Paulo , 03102, Brazil
São Paulo , 04520, Brazil
Edmonton Alberta, T6G 1, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Quebec , G1J 1, Canada
Chengdu , 61004, China
Guangzhou , 51006, China
Guiyang , 55000, China
Hangzhou , 31002, China
Hefei , 23000, China
Hefei , 23060, China
Shanghai , 20003, China
Shanghai , 20003, China
Shanghai , 20005, China
Urumqi , 83000, China
Wuhan , 43000, China
Xiamen , 36100, China
Zhengzhou , 45000, China
Frankfurt , 60488, Germany
Frankfurt , 60590, Germany
Hamburg , 20249, Germany
Leipzig , 04103, Germany
Mannheim , 68167, Germany
München , 81675, Germany
Milano , 20133, Italy
Milano , 20162, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Roma , 00168, Italy
Verona , 37134, Italy
Chuo-ku , 104-0, Japan
Kashiwa , 277-8, Japan
Kita-gun , 761-0, Japan
Ota-shi , 373-8, Japan
Seongnam-si , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Amsterdam , 1066C, Netherlands
Amsterdam , 1081 , Netherlands
Utrecht , 3584C, Netherlands
Gdańsk , 80-21, Poland
Konin , 62-50, Poland
Warszawa , 02-03, Poland
Arkhangelsk , 16304, Russian Federation
Chelyabinsk , 45408, Russian Federation
Kostroma , 15600, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 12528, Russian Federation
Moscow , 14342, Russian Federation
Moscow , 14344, Russian Federation
Novosibirsk , 63009, Russian Federation
Saint Petersburg , 19527, Russian Federation
Saint-Petersburg , 19702, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Tomsk , 63405, Russian Federation
Barcelona , 08035, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Santander , 39008, Spain
Sevilla , 41013, Spain
Kaohsiung , 80756, Taiwan
Kaohsiung , 83301, Taiwan
Tainan , 704, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 333, Taiwan
Cambridge , CB2 0, United Kingdom
Dundee , DD1 9, United Kingdom
London , NW1 2, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
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