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

  • STATUS
    Recruiting
  • End date
    Jul 14, 2023
  • participants needed
    255
  • sponsor
    AstraZeneca
Updated on 12 September 2021
fluorouracil
metastasis
oxaliplatin
metastatic adenocarcinoma
capecitabine
HER2
trastuzumab
cancer chemotherapy
adenocarcinoma
erbb2

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 durvalumab in HER2-positive advanced/metastatic gastric/gastroesophageal junction (GEJ) adenocarcinoma patients.

Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or durvalumab 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 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.

Details
Condition Gastropathy, Gastric Cancer, Stomach Discomfort, Gastric Carcinoma, Stomach Cancer, gastric cancers
Treatment Capecitabine, cisplatin, Trastuzumab, Oxaliplatin, durvalumab, Fluorouracil (5-Fu), Trastuzumab deruxtecan
Clinical Study IdentifierNCT04379596
SponsorAstraZeneca
Last Modified on12 September 2021

Eligibility

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 or GEJ with HER2 overexpression (IHC
+ or ICH 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
of the stomach or GEJ with HER2 overexpression
\. Has measurable target disease assessed by the Investigator based on RECIST
version 1.1
\. 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
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