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

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 c

Trial Details

NCT ID
NCT05372614
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography Test
  • Multigated Acquisition Scan
  • Neratinib Maleate
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311
  • Irvine, California, United States|33.66946,-117.82311
  • Lancaster, California, United States|34.69804,-118.13674
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

  • Patients must have histologically confirmed malignancy that is metastatic or unresectable with participation in this clinical trial determined to b…
  • Patients enrolling in Part 1 (Dose Escalation) may have a diagnosis of any solid tumor
  • Patients enrolling in the Part 2 Pharmacodynamic Cohort may have a diagnosis of any solid tumor except pancreas cancer (NOTE: pancreatic cancer exc…
  • Patients enrolling in the Part 2 Pancreatic Cohort must have a diagnosis of pancreatic adenocarcinoma (PDAC) and meet the HER2 positivity guidance

For full eligibility, visit ClinicalTrials.gov.

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