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

Recruiting now · Phase 2

Conditions studied: Gastric Cancer

In brief

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.

Key facts

Study ID: NCT04379596
Run by: AstraZeneca
People needed: 450
Starts: 2020-06-03
Expected to finish: 2027-06-01
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations
Disease Characteristics:
Locally advanced, unresectable, or metastatic disease based on most recent imaging
For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results
For Part 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results
For Part 1, progression on or after at least one prior trastuzumabcontaining regimen For Part 2, Part 3, Part 4 and Part 5, previously untreated for unresectable or metastatic adenocarcinoma of the stomach/GEJ/ esophagus with with HER2-positive (Part 2 and Part 3 [Arm 3A] and Part 4 [Arm 4A]) or HER2-low (Part 3 [Arm 3B], Part 4 [Arm 4B] and Part 5)) status
Has measurable target disease assessed by the Investigator based on RECIST version 1.1
Has protocol defined adequate bone marrow and 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.

You may not qualify if…

Part 1 to 4: History of active primary immunodeficiency, known HIV, active chronic, or past hepatitis B infection, or hepatitis C infection. Part 5: evidence of active, uncontroled HIV, 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.

Where it is running

Research Site — Frankfurt, Germany (enrolling)
Research Site — Milan, Italy (enrolling)
Research Site — Guangzhou, China (enrolling)
Research Site — Frankfurt, Germany (enrolling)
Research Site — Mannheim, Germany (enrolling)
Research Site — Milan, Italy (enrolling)
Research Site — Québec, Quebec, Canada (enrolling)
Research Site — Chengdu, China (enrolling)
Research Site — Shanghai, China (enrolling)
Research Site — Zhengzhou, China (enrolling)
Research Site — Hamburg, Germany (enrolling)
Research Site — Leipzig, Germany (enrolling)
Research Site — New York, New York, United States (enrolling)
Research Site — München, Germany (enrolling)
Research Site — Montreal, Quebec, Canada (enrolling)
Research Site — Santa Maria, Brazil (enrolling)
Research Site — São Jose Do Rio Preto, Brazil (enrolling)
Research Site — Houston, Texas, United States (enrolling)
Research Site — Boston, Massachusetts, United States (enrolling)
Research Site — Hefei, China (enrolling)
Research Site — Shanghai, China (enrolling)
Research Site — Shenyang, China (enrolling)
Research Site — Baltimore, Maryland, United States (enrolling)
Research Site — Toronto, Ontario, Canada (enrolling)
Research Site — Naples, Italy (enrolling)

Full record on ClinicalTrials.gov

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