Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated October 29, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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 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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-03-09; most recent amendment 2025-10-28.
Status change: Suspended → Recruiting 2024-03-14
Status change: Recruiting → Suspended 2023-10-12
Status change: Suspended → Recruiting 2023-07-10
Status change: Not Yet Recruiting → Suspended 2022-07-06
Trial Details
NCT Number NCT05274048
Lead Sponsor Fox Chase Cancer Center
Collaborators: National Comprehensive Cancer Network, Puma Biotechnology, Inc.
Conditions Gastric Cancer, Gastrointestinal Cancer, HER2 Gene Mutation
Enrollment 18 participants
Start Date 2022-06-24
Primary Completion 2026-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-10-29