Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients
Status:
Not yet recruiting
Trial end date:
2026-02-01
Target enrollment:
Participant gender:
Summary
This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety,
toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus
TDxD using a standard 3+3 dose escalation design in Patients with metastatic or unresectable
gastric adenocarcinoma (including GEJ tumors) that are HER2-overexpressing (IHC 3+ or
IHC2+/ISH+). Patients must have progressed or been intolerant of at least one prior line of
chemotherapy + HER2 directed therapy.