Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients

Study Number

3405022

Phase

Age Group

Adult

Principal Investigator

Purpose

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.

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Full Title

GI-200: A Multi-Center Phase I Trial of Neratinib and Fam-Trastuzumab Deruxtecan in
Advanced Refractory Gastric Cancer Patients

ClinicalTrials.Gov ID

NCT05274048

Get more information and eligibility criteria for this trial at ClinicalTrials.gov

To inquire about participating in these studies, call 1-800-ROSWELL (1-800-767-9355) or e-mail askroswell@roswellpark.org.