Active, not recruitingPhase II🇵🇱 PolandEN originalGastric cancerHER2 positiveMetastatic / advanced

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

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Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life. The main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth. Other aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study. The study will look at data already existing in the participants' medical charts.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek co najmniej 18 lat
  • •Zaawansowany, nieoperacyjny lub przerzutowy rak żołądka, połączenia żołądka z przełykiem lub przełyku
  • •Potwierdzony dodatni marker HER2 w badaniu tkanki
  • •Poprzednio leczeni na zaawansowaną chorobę lub bez poprzedniego leczenia (zależy od fazy badania)
  • •Mierzalne ogniska nowotworu widoczne w badaniach obrazowych
  • •Prawidłowa funkcja szpiku kostnego i narządów (serca, nerek, wątroby)
  • •Gotowość do stosowania antykoncepcji przez czas trwania badania

✗ Disqualifies

  • •Aktywne zapalenie pęcherzyków płucnych lub ziarniniające zapalenie płuc
  • •Niekontrolowana infekcja wymagająca antybiotyków dożylnych
  • •Aktywna lub niekontrolowana infekcja HIV, HBV lub HCV
  • •Niekontrolowana choroba wspótistniejąca
  • •Płyn w opłucnej, w jamie brzusznej lub w worku serca wymagający drenażu
  • •Poważne choroby płuc

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
130 Years
Last updated (source)
August 28, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (71)

Research Site

Baltimore, United States

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Boston, United States

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New York, United States

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Houston, United States

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Londrina, Brazil

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Ribeirão Preto, Brazil

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Santa Maria, Brazil

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São Jose Do Rio Preto, Brazil

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São Paulo, Brazil

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Toronto, Canada

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Montreal, Canada

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Québec, Canada

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Chengdu, China

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Guangzhou, China

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Hefei, China

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Shanghai, China

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Shenyang, China

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Wuhan, China

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Zhengzhou, China

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Frankfurt, Germany

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Frankfurt, Germany

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Hamburg, Germany

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Leipzig, Germany

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Mannheim, Germany

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München, Germany

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Milan, Italy

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Milan, Italy

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Naples, Italy

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Padova, Italy

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Roma, Italy

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Verona, Italy

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Chūōku, Japan

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Kashiwa, Japan

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Amsterdam, Netherlands

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Amsterdam, Netherlands

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Utrecht, Netherlands

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Gdansk, Poland

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Konin, Poland

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Koszalin, Poland

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Krakow, Poland

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Warsaw, Poland

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Kostroma, Russia

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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Novosibirsk, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Seongnam-si, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Santander, Spain

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Seville, Spain

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Kaohsiung City, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Cambridge, United Kingdom

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Dundee, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

Research Site

Sutton, United Kingdom

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/11/2026.

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