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
- Sponsor
- AstraZeneca
- Study ID
- NCT04989816
- Phase
- PHASE2
- Status
- Completed
Conditions
- Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Trastuzumab Deruxtecan — DRUGTrastuzumab deruxtecan (T-DXd) by intravenous infusion
Study Details
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
Key Dates
- Start date
- Aug 20, 2021
- Status verified
- Nov 2024
- Primary completion
- Jun 16, 2023
- Completion
- Feb 28, 2024
Study Design
- Enrollment
- 95 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: T-DXd armT-DXd monotherapy
Primary Outcome Measure
Confirmed Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR) [ Time Frame: 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 ]