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
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Male or female ≥ 18 years of age
- Pathologically documented gastric or GEJ adenocarcinoma
- Disease progression on or after ≥ 2 prior platinum and fluoropyrimidine agents for advanced/metastatic disease
- ECOG PS 0-1
- Willing and able to provide an adequate newly-acquired tumour sample for confirmation of HER2 status
- LVEF ≥ 50%
EXCLUSION CRITERIA
Exclusion Criteria:
- Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and CART. Drainage and CART.
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids
- Active primary immunodeficiency, known HIV, active HBV, HCV infection.
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- 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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Age (in years)
18+
Phase
Phase 2
Participants needed
95
Est. Completion Date
Feb 28, 2024
Treatment type
Interventional
Sponsor
AstraZeneca
ClinicalTrials.gov identifier
NCT04989816
Study number
D9676C00002
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