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    DRUG:

    patritumab deruxtecan (U3-1402)

    i
    Other names: U3-1402, U3 1402, U3-1402a, U31402, HER3 DXd, MK1022, MK 1022, U31402a, U3 1402a, Patritumab-DX-8951 conjugate, HER3-DXd, MK-1022, HER3DXd
    Company:
    Daiichi Sankyo, Merck (MSD)
    Drug class:
    Topoisomerase I inhibitor, HER3-targeted antibody-drug conjugate
    Related drugs:
    Apply
    A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors (HERTHENA-PanTumor01) (NCT06172478)
    Phase 2
    Daiichi Sankyo
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    02/26/2024
    Primary completion :
    06/30/2025
    Completion :
    04/30/2026
    ERBB3
    |
    patritumab deruxtecan (U3-1402)
    Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (ICARUS-BREAST01) (NCT04965766)
    Phase 2
    Gustave Roussy, Cancer Campus, Grand Paris
    Active, not recruiting
    Last update posted :
    02/10/2025
    Initiation :
    05/11/2021
    Primary completion :
    04/11/2025
    Completion :
    04/11/2028
    HER-2
    |
    HR positive • HER-2 negative
    |
    patritumab deruxtecan (U3-1402)
    Medical Access Program for Patritumab Deruxtecan (NCT06099639)
    Phase N/A
    Daiichi Sankyo
    Available
    Last update posted :
    02/06/2025
    ERBB3
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    patritumab deruxtecan (U3-1402)
    HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NCT04619004)
    Phase 2
    Daiichi Sankyo
    Active, not recruiting
    Last update posted :
    12/04/2024
    Initiation :
    02/02/2021
    Primary completion :
    11/21/2022
    Completion :
    01/30/2026
    ALK • ROS1
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ROS1 fusion
    |
    patritumab deruxtecan (U3-1402)
    U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer (U31402-A-U102) (NCT03260491)
    Phase 1
    Daiichi Sankyo
    Recruiting
    Last update posted :
    11/22/2024
    Initiation :
    10/30/2017
    Primary completion :
    03/31/2026
    Completion :
    12/31/2026
    ALK • ROS1
    |
    EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X
    |
    patritumab deruxtecan (U3-1402)
    Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer (U31402-A-J101) (NCT02980341)
    Phase 1/2
    Daiichi Sankyo Co., Ltd.
    Completed
    Last update posted :
    10/30/2024
    Initiation :
    11/28/2016
    Primary completion :
    08/16/2021
    Completion :
    09/07/2023
    HER-2 • ERBB3
    |
    HR positive • HER-2 negative • HER-2 expression • ERBB3 positive
    |
    patritumab deruxtecan (U3-1402)
    HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease (TUXEDO-3) (NCT05865990)
    Phase 2
    MedSIR
    Recruiting
    Last update posted :
    05/16/2024
    Initiation :
    11/24/2023
    Primary completion :
    12/31/2025
    Completion :
    10/01/2026
    HER-2 • ER • PGR • ERBB3 • TACSTD2
    |
    HER-2 positive • EGFR mutation • HER-2 expression • EGFR T790M • ERBB3 expression • TROP2 expression • ER expression • PGR expression
    |
    patritumab deruxtecan (U3-1402)
    A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases (PARAMETer) (NCT05620914)
    Phase 1
    Mustafa Khasraw, MBChB, MD, FRCP, FRACP
    Not yet recruiting
    Last update posted :
    02/14/2024
    Initiation :
    04/01/2024
    Primary completion :
    01/01/2025
    Completion :
    01/01/2027
    HER-2 • PGR • ERBB3
    |
    patritumab deruxtecan (U3-1402)
    Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT (NCT06222489)
    Phase 2
    The Netherlands Cancer Institute
    Not yet recruiting
    Last update posted :
    02/01/2024
    Initiation :
    05/01/2024
    Primary completion :
    05/01/2027
    Completion :
    05/01/2028
    ERBB3
    |
    patritumab deruxtecan (U3-1402)
    A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer (NCT04699630)
    Phase 2
    SCRI Development Innovations, LLC
    Recruiting
    Last update posted :
    01/24/2024
    Initiation :
    05/03/2021
    Primary completion :
    11/01/2025
    Completion :
    11/01/2025
    ER • ERBB3
    |
    HER-2 positive • HER-2 negative • HER-2 expression • ERBB3 expression
    |
    patritumab deruxtecan (U3-1402)
    NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial (NCT05569811)
    Phase 2
    SOLTI Breast Cancer Research Group
    Active, not recruiting
    Last update posted :
    09/21/2023
    Initiation :
    11/25/2022
    Primary completion :
    03/31/2025
    Completion :
    07/31/2030
    HER-2 • ER • PGR • ERBB3
    |
    ER positive • HER-2 negative • ERBB3 expression • PGR positive
    |
    paclitaxel • doxorubicin hydrochloride • cyclophosphamide • letrozole • epirubicin • patritumab deruxtecan (U3-1402)
    A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression (SOLTI TOT-HER3) (NCT04610528)
    Phase 1
    SOLTI Breast Cancer Research Group
    Active, not recruiting
    Last update posted :
    06/23/2023
    Initiation :
    12/22/2020
    Primary completion :
    01/30/2022
    Completion :
    09/30/2023
    HER-2 • ER • ERBB3
    |
    ER positive • HER-2 negative • ERBB3 expression
    |
    patritumab deruxtecan (U3-1402)