Trial intelligence / Profile preview

T-DXd + Ramucirumab in HER2-low Gastric/GEJ Cancer

NCT05894824Phase 2

Key facts

Status: Recruiting
Start: Feb 2024
Primary completion: Dec 2025
Countries: 1
Sponsor: Yonsei University
Modality: Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules

Drugs: trastuzumab deruxtecan
Conditions: gastric cancer (GC)gastroesophageal junction adenocarcinoma

Overview

Phase 2, open-label, single-arm trial of trastuzumab deruxtecan in gastric cancer (GC) and gastroesophageal junction adenocarcinoma, sponsored by Yonsei University. Primary endpoints: Recommended Phase 2 Dose at 6 weeks and Progression-Free Survival rate at 24 weeks. Started Feb 2024; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-label

T-DXd + Ramucirumab
Trastuzumab deruxtecan + Ramucirumab combination therapy

Who it enrols

Patients with metastatic or locally advanced HER2-low gastric or GEJ adenocarcinoma who have progressed after 1st line palliative treatment.

Endpoints

Primary

Recommended Phase 2 Dose6 weeks
Progression-Free Survival rate24 weeks

Secondary

Overall Survival6 months after last treatment
Objective Response Rate6 months after last treatment
Disease Control Rate6 months after last treatment
Duration of Response6 months after last treatment
Progression-Free Survival6 months after last treatment
Adverse Events6 months after last treatment

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