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

Studying safety of trastuzumab deruxtecan and neratinib for HER2 gene cancers.

Recruiting
18 years and older
All
Phase 1
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is exploring the safety and best dose of two anti-cancer drugs, neratinib and trastuzumab deruxtecan, for treating cancers that have spread or can't be removed by surgery due to changes in the HER2 gene. The HER2 gene can affect how cancer cells grow. Neratinib is a kinase inhibitor, which helps stop cancer cells from multiplying. Trastuzumab deruxtecan is an antibody-drug conjugate, which targets and kills cancer cells. The study aims to find out how well these drugs work together against cancer.

  • This study involves taking neratinib daily and receiving trastuzumab deruxtecan every 21 days.
  • Participants will have regular check-ups, including CT scans and blood tests.
  • After completing the study treatment, follow-up visits are every three months for at least a year.

Participants must be adults (18+), have certain types of cancer with HER2 gene changes, and not have used neratinib or trastuzumab deruxtecan before. There are specific health requirements to join, and certain medications and conditions are not allowed.

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Study details
    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

NCT05372614

National Cancer Institute (NCI)

12 September 2026

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