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 Overexpressing Gastric Cancer (DESTINY-Gastric03) (DG-03)

  • End date
    Oct 13, 2023
  • participants needed
  • sponsor
Updated on 12 October 2022
metastatic adenocarcinoma
cancer chemotherapy


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.

Condition Gastric Cancer
Treatment Capecitabine, cisplatin, Trastuzumab, Pembrolizumab, Oxaliplatin, durvalumab, Fluorouracil (5-Fu), Trastuzumab deruxtecan
Clinical Study IdentifierNCT04379596
Last Modified on12 October 2022


Yes No Not Sure

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
Has measurable target disease assessed by the Investigator based on RECIST version 1.1
of the stomach, GEJ or esophagus with HER2 overexpression
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
Clear my responses

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