At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Locally advanced, unresectable, or metastatic disease on recent imaging
- ✓Pathologically documented adenocarcinoma of stomach/GEJ/esophagus
- ✓HER2-positive (IHC 3+ or IHC 2+/ISH+) for Parts 1-4a
- ✕Parts 1-4: Active primary immunodeficiency, known HIV, active/past hepatitis B, hepatitis C
- ✕Part 5: Active uncontrolled HIV, HBV, or HCV infection
- ✕Uncontrolled intercurrent illness
- ✕History of non-infectious pneumonitis/ILD, current ILD, or suspected ILD not ruled out by imaging
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Fluorouracil (5-FU), Capecitabine, and 8 other interventions for Gastric Cancer. Currently recruiting, targeting 450 participants across 100 sites in 14 countries.
Detailed 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.
Study Details
Timeline
Arms & Interventions
T-DXd and 5-fluorouracil (5-FU)
T-DXd and capecitabine
T-DXd and durvalumab
T-DXd, capecitabine, and oxaliplatin
T-DXd, 5-FU, and durvalumab
T-DXd, capecitabine, and durvalumab
Trastuzumab, 5-FU or capecitabine, and cisplatin or oxaliplatin
T-DXd monotherapy
T-DXd, 5-FU or capecitabine
T-DXd, pembrolizumab and 5-FU or capecitabine
T-DXd and pembrolizumab
T-DXd, pembrolizumab and 5-FU or capecitabine
T-DXd, Volrustomig and 5-FU or capecitabine
T-DXd, Volrustomig and 5-FU or capecitabine
T-DXd, Rilvegostomig and 5-FU or capecitabine
T-DXd, Rilvegostomig and 5-FU or capecitabine
T-DXd, Volrustomig and 5-FU or capecitabine
T-DXd, Volrustomig and 5-FU or capecitabine
Interventions
5-FU: administered as an IV infusion
Capecitabine: administered orally
Durvalumab: administered as an IV infusion
Oxaliplatin: administered as an IV infusion
Trastuzumab: administered as an IV infusion
T-DXd: administered as an IV infusion
Cisplatin: administered as an IV infusion
Pembrolizumab: administered as an IV infusion
Volrustomig: administered as an IV infusion
Rilvegostomig: administered as an IV infusion