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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony nowotwór stały, który się rozprzestrzeniał (przerzuty) lub nie można go usunąć operacyjnie
  • Nowotwór musi mieć dodatni HER2 (określony testami laboratoryjnymi)
  • Leczenie w tym badaniu musi być uznane za najlepszą opcję dalszego leczenia
  • W części badania dotyczącej trzustki: potwierdzony rak trzustki (adenokarcynoma) z dodatnim HER2

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 24, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (18)

City of Hope Comprehensive Cancer Center

Duarte, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, United States

City of Hope at Irvine Lennar

Irvine, United States

City of Hope Antelope Valley

Lancaster, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, United States

University of California Davis Comprehensive Cancer Center

Sacramento, United States

City of Hope South Pasadena

South Pasadena, United States

City of Hope Upland

Upland, United States

UF Health Cancer Institute - Gainesville

Gainesville, United States

Northwestern University

Chicago, United States

University of Kentucky/Markey Cancer Center

Lexington, United States

Dana-Farber Cancer Institute

Boston, United States

Washington University School of Medicine

St Louis, United States

Ohio State University Comprehensive Cancer Center

Columbus, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, United States

UT MD Anderson Cancer Center

Houston, United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, United States

Trial contact

Dani R. Castillo

PRINCIPAL_INVESTIGATOR

Site Public Contact

Farshid Dayyani

PRINCIPAL_INVESTIGATOR

Site Public Contact

Site Public Contact

Mili Arora

PRINCIPAL_INVESTIGATOR

Site Public Contact

Thomas J. George

PRINCIPAL_INVESTIGATOR

Aparna Kalyan

PRINCIPAL_INVESTIGATOR

Site Public Contact

Reema A. Patel

PRINCIPAL_INVESTIGATOR

Site Public Contact

Haeseong Park

PRINCIPAL_INVESTIGATOR

Andrew Davis

PRINCIPAL_INVESTIGATOR

Floor Backes

PRINCIPAL_INVESTIGATOR

Site Public Contact

Sarah E. Taylor

PRINCIPAL_INVESTIGATOR

Ecaterina E. Ileana Dumbrava

PRINCIPAL_INVESTIGATOR

Nataliya V. Uboha

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/26/2026.

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