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Contact Information:

AstraZeneca Clinical Study Information Center 1-877-240-9479
information.center@astrazeneca.com


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

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

Recruiting

Open to: ALL

Age: 18.0 - 130.0

Medical Conditions

Stomach Neoplasms


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jun 2020 Jul 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 5-FU: administered as an IV infusion

Intervention Arm Group : Arm 1A;Arm 1E(a);Arm 2A;Arm 2C;Arm 2D;Arm 2F;Arm 3A;Arm 3B;Arm 4A;Arm 4B;

Intervention Type : DRUG
Intervention Description : Capecitabine: administered orally

Intervention Arm Group : Arm 1B;Arm 1D(b);Arm 1E(b);Arm 2A;Arm 2C;Arm 2D;Arm 2F;Arm 3A;Arm 3B;Arm 4A;Arm 4B;

Intervention Type : BIOLOGICAL
Intervention Description : Durvalumab: administered as an IV infusion

Intervention Arm Group : Arm 1C;Arm 1E(a);Arm 1E(b);

Intervention Type : DRUG
Intervention Description : Oxaliplatin: administered as an IV infusion

Intervention Arm Group : Arm 1D(b);Arm 2A;

Intervention Type : BIOLOGICAL
Intervention Description : Trastuzumab: administered as an IV infusion

Intervention Arm Group : Arm 2A;

Intervention Type : DRUG
Intervention Description : T-DXd: administered as an IV infusion

Intervention Arm Group : Arm 1A;Arm 1B;Arm 1C;Arm 1D(b);Arm 1E(a);Arm 1E(b);Arm 2B;Arm 2C;Arm 2D;Arm 2E;Arm 2F;Arm 3A;Arm 3B;Arm 4A;Arm 4B;

Intervention Type : DRUG
Intervention Description : Cisplatin: administered as an IV infusion

Intervention Arm Group : Arm 2A;

Intervention Type : BIOLOGICAL
Intervention Description : Pembrolizumab: administered as an IV infusion

Intervention Arm Group : Arm 2D;Arm 2E;Arm 2F;

Intervention Type : BIOLOGICAL
Intervention Description : Volrustomig: administered as an IV infusion

Intervention Arm Group : Arm 3A;Arm 3B;

Intervention Type : BIOLOGICAL
Intervention Description : Rilvegostomig: administered as an IV infusion

Intervention Arm Group : Arm 4A;Arm 4B;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Research Site
    Cambridge
    CB2 0QQ
  • Research Site
    Dundee
    DD1 9SY
  • Research Site
    London
    NW1 2PG
  • Research Site
    Manchester
    M20 4BX
  • Research Site
    Sutton
    SM2 5PT

AstraZeneca Clinical Study Information Center 1-877-240-9479
information.center@astrazeneca.com



The study is sponsored by AstraZeneca and is in collaboration with Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo.




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Read full details for Trial ID: NCT04379596
Last updated 14 March 2025

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