RecruitingPhase 2NCT04379596

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

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)

Sponsor

AstraZeneca

Enrollment

450 participants

Start Date

Jun 3, 2020

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study tests trastuzumab deruxtecan (T-DXd), an antibody-drug therapy targeting HER2, in combination with other treatments for people with advanced stomach or esophageal cancer. Different combinations and patient groups are being tested across multiple study parts, including first-line and later-line treatment settings. **You may be eligible if...** - You are 18 or older - You have confirmed adenocarcinoma (a type of cancer) of the stomach, esophagus, or the junction between them - Your cancer is HER2-positive or HER2-low (confirmed by laboratory testing) - Your cancer is locally advanced, unresectable, or metastatic - You meet organ function requirements (heart, liver, kidneys) - If you are female and of childbearing potential, you agree to use effective contraception **You may NOT be eligible if...** - You have active HIV (or uncontrolled HIV), active hepatitis B or C - You have uncontrolled other illnesses - You have a history of lung disease (interstitial lung disease/pneumonitis) - You have significant fluid around your lungs, heart, or abdomen requiring drainage - You have active or symptomatic cancer in the brain or spinal cord Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluorouracil (5-FU)

5-FU: administered as an IV infusion

DRUGCapecitabine

Capecitabine: administered orally

BIOLOGICALDurvalumab

Durvalumab: administered as an IV infusion

DRUGOxaliplatin

Oxaliplatin: administered as an IV infusion

BIOLOGICALTrastuzumab

Trastuzumab: administered as an IV infusion

DRUGTrastuzumab deruxtecan

T-DXd: administered as an IV infusion

DRUGCisplatin

Cisplatin: administered as an IV infusion

BIOLOGICALPembrolizumab

Pembrolizumab: administered as an IV infusion

BIOLOGICALVolrustomig

Volrustomig: administered as an IV infusion

BIOLOGICALRilvegostomig

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

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Toronto, Ontario, Canada

Research Site

Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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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, 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

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NCT04379596

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