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Study identifier: NCT05372614 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Metastatic Malignant Solid Neoplasm · Metastatic Pancreatic Adenocarcinoma · Stage III Pancreatic Cancer AJCC v8  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 1
Planned participants58
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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. This helps slow or stop the spread of tumor cells. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Adding neratinib to trastuzumab deruxtecan may be able to shrink cancer with a change in the HER2 gene.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

Always discuss trial participation with your own doctor first.

Locations (18)

City of Hope Comprehensive Cancer CenterDuarte, California, United StatesRecruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California, United StatesRecruiting
City of Hope at Irvine LennarIrvine, California, United StatesRecruiting
City of Hope Antelope ValleyLancaster, California, United StatesRecruiting
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California, United StatesRecruiting
University of California Davis Comprehensive Cancer CenterSacramento, California, United StatesRecruiting
City of Hope South PasadenaSouth Pasadena, California, United StatesRecruiting
City of Hope UplandUpland, California, United StatesRecruiting
UF Health Cancer Institute - GainesvilleGainesville, Florida, United StatesRecruiting
Northwestern UniversityChicago, Illinois, United StatesRecruiting
University of Kentucky/Markey Cancer CenterLexington, Kentucky, United StatesRecruiting
Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting

+ 6 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05372614