Phase I Trial of DS-8201a (Trastuzumab Deruxtecan) in Combination With Neratinib in Solid Tumors With HER2 Alterations

This study is testing a combination of two targeted cancer drugs to see how well they work and how safe they are for patients with advanced or non-removable solid tumors. The goal is to see if combining these medicines can better stop cancer cells with a specific HER2 gene change from growing and spreading.

You may be eligible if you have a biopsy-confirmed solid tumor—specifically pancreatic cancer—that has spread or cannot be removed by surgery and tests positive for the HER2 protein or gene. You must also be off other cancer treatments for a set period and meet specific health criteria set by the study doctors.

Participants will receive the study medications and undergo regular monitoring, including blood tests, physical exams, and imaging scans like CT scans or heart function tests. You will also have tissue samples collected to help the medical team track how your cancer responds to the treatment.

The study is currently recruiting patients at medical centers in Duarte and Irvine, California. Since it is a Phase I trial, it is an early-stage study focused on finding the safest and most effective dose for these combined medications.