OncoMatch/Clinical Trials/NCT04379596
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
Is NCT04379596 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for gastric cancer.
Treatment: Fluorouracil (5-FU) · Capecitabine · Durvalumab · Oxaliplatin · Trastuzumab · Trastuzumab deruxtecan · Cisplatin · Pembrolizumab · Volrustomig · Rilvegostomig — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) IHC 3+ (IHC 3+)
HER2-positive (IHC 3+ ... based on local tissue testing results)
Required: HER2 (ERBB2) IHC 2+/ISH+ (IHC 2+/ISH+)
HER2-positive (IHC 2+/ISH+ ... based on local tissue testing results)
Required: HER2 (ERBB2) IHC 2+/ISH- (IHC 2+/ISH-)
HER2-low (IHC 2+/ISH-negative ... based on local tissue testing results)
Required: HER2 (ERBB2) IHC 1+ (IHC 1+)
HER2-low (IHC 1+ ... based on local tissue testing results)
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab) — Part 1
For Part 1, progression on or after at least one prior trastuzumab-containing regimen
Lab requirements
Blood counts
protocol defined adequate bone marrow function
Kidney function
protocol defined adequate renal function
Liver function
protocol defined adequate hepatic function
Cardiac function
protocol defined adequate cardiac function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Santa Monica, California
- Research Site · Westwood, Kansas
- Research Site · Baltimore, Maryland
- Research Site · Boston, Massachusetts
- Research Site · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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