Esophageal Cancer Clinical Trial

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2+ Gastric Cancer (DESTINY-Gastric03)

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-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.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Male and female participants must be at least 18 years of age

Disease Characteristics:

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.

Exclusion criteria:

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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

315

Study ID:

NCT04379596

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 93 Locations for this study

See Locations Near You

Research Site
Santa Monica California, 90404, United States
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Westwood Kansas, 66205, United States
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Baltimore Maryland, 21287, United States
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Boston Massachusetts, 02114, United States
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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
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Houston Texas, 77090, United States
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Fairfax Virginia, 22031, United States
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Florianopolis , 88020, Brazil
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Londrina , 86015, Brazil
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Natal , 59075, Brazil
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Porto Alegre , 90160, Brazil
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Ribeirão Preto , 14051, Brazil
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Rio de Janeiro , 22793, Brazil
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Santa Maria , 97015, Brazil
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Sao Paulo , 01509, Brazil
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São Jose do Rio Preto , 15090, Brazil
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São Paulo , 03102, Brazil
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São Paulo , 04520, Brazil
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Edmonton Alberta, T6G 1, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 2, Canada
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Quebec , G1J 1, Canada
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Chengdu , 61004, China
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Guangzhou , 51006, China
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Guiyang , 55000, China
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Hangzhou , 31002, China
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Hefei , 23000, China
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Hefei , 23060, China
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Shanghai , 20003, China
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Shanghai , 20003, China
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Shanghai , 20005, China
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Urumqi , 83000, China
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Wuhan , 43000, China
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Xiamen , 36100, China
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Zhengzhou , 45000, China
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Frankfurt , 60488, Germany
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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
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Milano , 20133, Italy
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Milano , 20162, Italy
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Napoli , 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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Chuo-ku , 104-0, Japan
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Kashiwa , 277-8, Japan
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Kita-gun , 761-0, Japan
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Ota-shi , 373-8, Japan
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Amsterdam , 1066C, Netherlands
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Amsterdam , 1081 , Netherlands
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Utrecht , 3584C, Netherlands
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Gdańsk , 80-21, Poland
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Konin , 62-50, Poland
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Warszawa , 02-03, Poland
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Arkhangelsk , 16304, Russian Federation
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Chelyabinsk , 45408, Russian Federation
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Kostroma , 15600, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 12528, Russian Federation
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Moscow , 14342, Russian Federation
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Moscow , 14344, Russian Federation
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Novosibirsk , 63009, Russian Federation
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Saint Petersburg , 19527, Russian Federation
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Saint-Petersburg , 19702, Russian Federation
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Saint-Petersburg , 19775, Russian Federation
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Tomsk , 63405, Russian Federation
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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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Sevilla , 41013, Spain
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Kaohsiung , 80756, Taiwan
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Kaohsiung , 83301, Taiwan
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Tainan , 704, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 11217, Taiwan
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Taoyuan , 333, Taiwan
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Cambridge , CB2 0, United Kingdom
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Dundee , DD1 9, United Kingdom
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London , NW1 2, United Kingdom
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Manchester , M20 4, United Kingdom
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Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

315

Study ID:

NCT04379596

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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