NCT04014075

DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)

A Phase 2, Open-label, Single-arm Trial of Trastuzumab Deruxtecan (DS 8201a) in HER2-positive, Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-containing Regimen (DESTINY-Gastric02)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer. They must have human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction (GEJ) cancer: * that cannot be removed surgically * that has moved to other parts of the body * that got worse during or after treatment that included trastuzumab The study will enroll about 80 participants. Sites will be in North America and the European Union.

Conditions

• Adenocarcinoma Gastric Stage IV With Metastases
• Adenocarcinoma - GEJ

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion

Timeline

• Start date: 2019-11-26
• Primary completion: 2021-11-08
• Completion: 2024-02-13
• First posted: 2019-07-10
• Last updated: 2025-04-03
• Results posted: 2022-01-12

Locations

37 sites across 5 countries: United States, Belgium, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study