Phase 2
Completed N=95
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
Source: ClinicalTrials.gov NCT04989816 ↗Enrolled (actual)
95
Serious AEs
42.1%
Results posted
Nov 2024
Primary outcomePrimary: Confirmed Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR) — 28.8 Percentage of Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR) |
28.8 | — |
| PRIMARY Best Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR) |
1; 20; 37; 14; 1 | — |
| SECONDARY Progression-free Survival (PFS) Based on Independent Central Review (ICR) |
5.7 | — |
| SECONDARY Progression-free Survival (PFS) Rate at 3 Months Based on Independent Central Review (ICR) |
69.0 | — |
| SECONDARY Progression-free Survival (PFS) Rate at 6 Months Based on Independent Central Review (ICR) |
43.4 | — |
| SECONDARY Progression-free Survival (PFS) Rate at 9 Months Based on Independent Central Review (ICR) |
27.1 | — |
| SECONDARY Progression-free Survival (PFS) Rate at 12 Months Based on Independent Central Review (ICR) |
16.7 | — |
| SECONDARY Progression-free Survival (PFS) Rate at 15 Months Based on Independent Central Review (ICR) |
11.9 | — |
| SECONDARY Progression-free Survival (PFS) Rate at 18 Months Based on Independent Central Review (ICR) |
4.0 | — |
| SECONDARY Progression-free Survival (PFS) Rate at 21 Months Based on Independent Central Review (ICR) |
4.0 | — |
| SECONDARY Disease Control Rate (DCR) Based on Independent Central Review (ICR) |
79.5 | — |
| SECONDARY Disease Control Rate (DCR) Based on Independent Central Review (ICR) at Week 12 |
74.0 | — |
| SECONDARY Duration of Response (DoR) Based on Independent Central Review (ICR) |
6.7 | — |
| SECONDARY Overall Survival (OS) Based on Independent Central Review (ICR) |
11.1 | — |
| SECONDARY Best Percentage Change in Sum of Diameters of Measurable Tumours Based on Independent Central Review (ICR) |
-22.55 | — |
Eligibility 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
- 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.
Data sourced from ClinicalTrials.gov (NCT04989816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.