Clinical trial · Interventional
Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens
A Single-arm Study of Trastuzumab Deruxtecan (T-DXd) Monotherapy for Patients With HER2-expressing Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Who Have Received 2 or More Prior Regimens (DESTINY-Gastric06)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II, open-label, single-arm, multicentre, study in China assessing the efficacy and safety of T-DXd in participants with HER2-expressing advanced gastric or GEJ adenocarcinoma who have received at least 2 prior regimens including a fluoropyrimidine agent and a platinum agent
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab Deruxtecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- T-DXd arm
- description
- T-DXd monotherapy
- interventionNames
- Drug: Trastuzumab Deruxtecan
Primary outcomes (2)
- measure
- Confirmed Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR)
- timeFrame
- Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 months
- description
- Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1.
- measure
- Best Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR)
- timeFrame
- Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female ≥ 18 years of age 2. Pathologically documented gastric or GEJ adenocarcinoma 3. Disease progression on or after ≥ 2 prior platinum and fluoropyrimidine agents for advanced/metastatic disease 4. ECOG PS 0-1 5. Willing and able to provide an adequate newly-acquired tumour sample for confirmation of HER2 status 6. LVEF ≥ 50% Exclusion Criteria: 1. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and CART. Drainage and CART. 2. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids 3. Active primary immunodeficiency, known HIV, active HBV, HCV infection. 4. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. 5. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening. 6. Lung-specific intercurrent clinically significant severe illnesses.
References
Publications (0)
Data not yet available