Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene

Summary

This phase I trial tests the safety, side effects, and best dose of neratinib in combination with trastuzumab deruxtecan in treating patients with solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable), and have changes in a gene called human epidermal growth factor receptor 2 (HER2). Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Metastatic Malignant Solid Neoplasm
• Metastatic Pancreatic Adenocarcinoma
• Stage III Pancreatic Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8
• Unresectable Malignant Solid Neoplasm
• Unresectable Pancreatic Adenocarcinoma

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

National Cancer Institute (NCI)

Last updated on ClinicalTrials.gov

October 2, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites