For Healthcare Professionals

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

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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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

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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