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    BIOMARKER:

    HER-2 underexpression

    i
    Entrez ID:
    2064
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    Apply
    DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer (KEYNOTE-797) (NCT04042701)
    Phase 1
    Daiichi Sankyo
    Active, not recruiting
    Last update posted :
    02/24/2025
    Initiation :
    02/10/2020
    Primary completion :
    07/01/2025
    Completion :
    08/01/2025
    EGFR • HER-2 • BRAF • ALK • ROS1
    |
    HER-2 positive • BRAF V600E • EGFR mutation • HR positive • BRAF V600 • HER-2 expression • HER-2 underexpression • ALK mutation • ROS1 fusion
    |
    Keytruda (pembrolizumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) (NCT06018337)
    Phase 3
    DualityBio Inc.
    Recruiting
    Last update posted :
    02/06/2025
    Initiation :
    01/18/2024
    Primary completion :
    12/01/2025
    Completion :
    05/01/2028
    HER-2 • PGR
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression • PGR positive
    |
    capecitabine • albumin-bound paclitaxel • trastuzumab pamirtecan (BNT323)
    A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer (DESTINY-Breast08) (NCT04556773)
    Phase 1
    AstraZeneca
    Active, not recruiting
    Last update posted :
    02/05/2025
    Initiation :
    12/17/2020
    Primary completion :
    08/16/2023
    Completion :
    12/04/2025
    HER-2 • PGR
    |
    HER-2 expression • HER-2 underexpression • PGR positive
    |
    Imfinzi (durvalumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • fulvestrant • Truqap (capivasertib) • anastrozole
    A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein (NCT04147819)
    Phase 1
    Bayer
    Completed
    Last update posted :
    09/27/2024
    Initiation :
    07/02/2020
    Primary completion :
    08/21/2023
    Completion :
    09/26/2023
    HER-2
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 underexpression
    |
    BAY2701439 • BAY2701438
    Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01) (NCT04152499)
    Phase 1/2
    Klus Pharma Inc.
    Recruiting
    Last update posted :
    06/24/2024
    Initiation :
    02/28/2020
    Primary completion :
    08/01/2025
    Completion :
    07/16/2026
    EGFR • HER-2 • MSI • BRCA • TACSTD2
    |
    MSI-H/dMMR • HER-2 negative • HER-2 expression • EGFR wild-type • HER-2 underexpression • TROP2 expression • BRCA mutation
    |
    Jiataile (sacituzumab tirumotecan)
    A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors (NCT06031584)
    Phase 1/2
    Sichuan Baili Pharmaceutical Co., Ltd.
    Recruiting
    Last update posted :
    03/08/2024
    Initiation :
    01/19/2024
    Primary completion :
    03/01/2026
    Completion :
    03/01/2026
    HER-2
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    BL-M07D1
    DESTINY Breast Respond HER2-low Europe (NCT05945732)
    Phase N/A
    Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo C...
    Recruiting
    Last update posted :
    03/07/2024
    Initiation :
    10/24/2023
    Primary completion :
    06/01/2027
    Completion :
    09/01/2028
    HER-2
    |
    HER-2 expression • HER-2 underexpression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate)
    Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer (NCT06105008)
    Phase 2
    RemeGen Co., Ltd.
    Not yet recruiting
    Last update posted :
    02/21/2024
    Initiation :
    12/20/2024
    Primary completion :
    12/20/2025
    Completion :
    04/10/2026
    HER-2 • ER
    |
    HER-2 expression • HER-2 underexpression • PGR expression
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors (NCT05461768)
    Phase 1
    Sichuan Baili Pharmaceutical Co., Ltd.
    Recruiting
    Last update posted :
    01/31/2024
    Initiation :
    08/09/2022
    Primary completion :
    08/01/2024
    Completion :
    08/01/2024
    HER-2
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    BL-M07D1
    Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors (DS8201-A-J101) (NCT02564900)
    Phase 1
    Daiichi Sankyo Co., Ltd.
    Completed
    Last update posted :
    01/22/2024
    Initiation :
    09/01/2015
    Primary completion :
    02/01/2019
    Completion :
    12/22/2023
    HER-2
    |
    HER-2 positive • HER-2 overexpression • HER-2 mutation • HER-2 underexpression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer (NCT05911958)
    Phase 2
    Henan Cancer Hospital
    Recruiting
    Last update posted :
    12/20/2023
    Initiation :
    07/05/2023
    Primary completion :
    05/31/2024
    Completion :
    05/31/2029
    HER-2
    |
    HR positive • HER-2 expression • HER-2 underexpression
    |
    trastuzumab rezetecan (SHR-A1811)
    A Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HF158K1 in Participants With HER-2 Positive or HER-2 Low Expression Advanced Solid Tumors (NCT05861895)
    Phase 1
    HighField Biopharmaceuticals Corporation
    Recruiting
    Last update posted :
    12/15/2023
    Initiation :
    12/12/2023
    Primary completion :
    04/23/2025
    Completion :
    12/22/2025
    HER-2
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    HF158K1
    Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status (RosHER) (NCT05217381)
    Phase N/A
    MedSIR
    Completed
    Last update posted :
    09/25/2023
    Initiation :
    02/22/2022
    Primary completion :
    09/20/2023
    Completion :
    09/20/2023
    HER-2 • ER • PGR
    |
    HER-2 positive • HER-2 negative • HER-2 expression • HER-2 underexpression • HER-2 positive + HER-2 overexpression
    DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease (DEBBRAH) (NCT04420598)
    Phase 2
    MedSIR
    Completed
    Last update posted :
    09/07/2023
    Initiation :
    05/25/2020
    Primary completion :
    09/30/2021
    Completion :
    04/04/2023
    HER-2
    |
    HER-2 positive • HER-2 negative • HER-2 expression • HER-2 underexpression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression. (NCT05845138)
    Phase 1/2
    Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    Recruiting
    Last update posted :
    08/01/2023
    Initiation :
    07/25/2023
    Primary completion :
    12/31/2024
    Completion :
    12/31/2025
    HER-2
    |
    HER-2 expression • HER-2 underexpression
    |
    capecitabine • trastuzumab rezetecan (SHR-A1811)
    Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer (Conerstone3) (NCT05771584)
    Phase 2
    Aston Sci. Inc.
    Recruiting
    Last update posted :
    07/20/2023
    Initiation :
    07/04/2023
    Primary completion :
    10/15/2023
    Completion :
    06/15/2026
    HER-2 • CD8 • CD4
    |
    HER-2 overexpression • HER-2 underexpression
    |
    AST-301 • Leukine (sargramostim)
    The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression (NCT05861635)
    Phase 4
    Wuhan Union Hospital, China
    Recruiting
    Last update posted :
    05/17/2023
    Initiation :
    02/01/2023
    Primary completion :
    02/01/2025
    Completion :
    02/01/2026
    HER-2 • ER • PGR
    |
    ER positive • HER-2 expression • HER-2 underexpression • PGR positive • PGR negative
    |
    Tevimbra (tislelizumab-jsgr) • Aidixi (disitamab vedotin)
    Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer (NCT05466786)
    Phase N/A
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Un...
    Not yet recruiting
    Last update posted :
    07/20/2022
    Initiation :
    07/15/2022
    Primary completion :
    05/31/2027
    Completion :
    05/31/2027
    HER-2
    |
    HER-2 expression • HER-2 underexpression
    ARX788 in Breast Cancer With Low Expression of HER2 (NCT05018676)
    Phase 2
    Fudan University
    Recruiting
    Last update posted :
    04/25/2022
    Initiation :
    10/20/2021
    Primary completion :
    12/30/2022
    Completion :
    06/30/2023
    HER-2
    |
    HER-2 positive • HR positive • HER-2 expression • HER-2 underexpression
    |
    anvatabart opadotin (JNJ-0683)
    Study of DP303c Injection in Patients With Advanced Ovarian Cancer (NCT04828616)
    Phase 2
    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    Not yet recruiting
    Last update posted :
    04/02/2021
    Initiation :
    07/01/2021
    Primary completion :
    07/01/2023
    Completion :
    07/01/2024
    HER-2
    |
    HER-2 overexpression • HER-2 underexpression
    |
    trastuzumab envedotin (DP303c)
    Study of DP303c Injection in Patients With Advanced or Metastatic Gastric Cancer (NCT04826107)
    Phase 2
    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    Not yet recruiting
    Last update posted :
    04/01/2021
    Initiation :
    08/01/2021
    Primary completion :
    08/01/2024
    Completion :
    12/01/2024
    HER-2
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    trastuzumab envedotin (DP303c)
    Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer (NATURE) (NCT02725541)
    Phase 2
    Jenny C. Chang, MD
    Withdrawn
    Last update posted :
    09/14/2016
    Initiation :
    03/01/2016
    Primary completion :
    04/01/2019
    Completion :
    05/01/2019
    HER-2
    |
    HER-2 expression • HER-2 underexpression
    |
    Kadcyla (ado-trastuzumab emtansine)