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

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05372614
Phase
PHASE1
Status
Suspended

Conditions

  • Metastatic Malignant Solid Neoplasm
  • Unresectable Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Echocardiography Test — PROCEDURE
    Undergo echocardiography
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Neratinib Maleate — DRUG
    Given PO
  • Trastuzumab Deruxtecan — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Oct 5, 2022
Status verified
Jan 2026
Primary completion
Sep 17, 2025
Completion
Jan 23, 2027

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (neratinib, trastuzumab deruxtecan)
    Patients receive neratinib PO QD on days 1-21 (days 8-21 of cycle 1, then days 1-21 in cycles thereafter for PD study) of each cycle and trastuzumab deruxtecan IV over 30-90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, CT scan and echocardiography or MUGA scan throughout study. Additionally, patients may undergo a tissue biopsy at baseline and disease progression.

Primary Outcome Measure

Incidence of dose limiting toxicities [ Time Frame: In the first 2 cycles in dose escalation of combination of neratinib and trastuzumab deruxtecan (DS-8201a) (cycle length = 21 days) ]

Locations (18)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
City of Hope at Irvine LennarIrvineCalifornia92618-
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612-
City of Hope Antelope ValleyLancasterCalifornia93534-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
City of Hope UplandUplandCalifornia91786-
UF Health Cancer Institute - GainesvilleGainesvilleFlorida32610-
Northwestern UniversityChicagoIllinois60611-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Washington University School of MedicineSt LouisMissouri63110-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
M D Anderson Cancer CenterHoustonTexas77030-
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadisonWisconsin53718-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CACity of Hope at Irvine Lennar· Irvine, CAUCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CACity of Hope Antelope Valley· Lancaster, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CA

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