Gastric/Gastro-esophageal Junction Cancer MSK 19-377

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
This study will find out if trastuzumab deruxtecan is safe and works for participants with certain kinds of cancer.
They must have 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 72 participants at about 25 to 30 sites. Sites will be in North America, Australia, Israel, and the European Union. There might be other countries as well.
Eligibility Criteria:
  • Pathologically documented gastric or GEJ cancer that is:
  • Unresectable or metastatic, and
  • Centrally confirmed HER2-positive disease (IHC3+ or IHC2+ and evidence of HER2 amplification by ISH)
  • Experienced disease progression (based on RECIST 1.1) during or after first-line therapy with a trastuzumab-containingregimen.
  • Presence of at least 1 measurable lesion per RECIST v1.1
  • LVEF ≥50% within 28 days before enrollment per ECHO/MUGA scan
Available at: Hartford Hospital, Hospital of Central Connecticut, Midstate Medical Center, William Backus Hospital.