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A Multi-Center Phase I Trial of Neratinib and Fam-trastuzumab Deruxtecan in Advanced Refractory Gastric and Esophageal Cancer Patients
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 gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+/ISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.
Details
| Lead sponsor | Fox Chase Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 18 |
| Start date | 2022-06-24 |
| Completion | 2027-06 |
Conditions
- Gastric Cancer
- Gastrointestinal Cancer
- HER2 Gene Mutation
Interventions
- Neratinib Pill
- Fam-Trastuzumab Deruxtecan-Nxki (TDxD)
Primary outcomes
- Determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of TDxD and Neratinib — 2 years
The rate of dose-limiting toxicities (DLTs) for Neratinib + TDxD during DLT period of 28 days, in patients with advanced gastrointestinal cancer
Countries
United States