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    DRUG:

    GQ1001

    i
    Other names: GQ1001
    Company:
    GeneQuantum Healthcare
    Drug class:
    Microtubule inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    9ms
    GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=75, Recruiting, Fudan University | Active, not recruiting --> Recruiting | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Enrollment open • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    capecitabine • Irene (pyrotinib) • GQ1001
    over1year
    Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=96, Recruiting, GeneQuantum Healthcare (Suzhou) Co., Ltd. | Trial primary completion date: Dec 2022 --> Mar 2024
    Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    GQ1001
    over1year
    GQ1001: A next generation HER2-targeting ADC that exhibits promising early clinical efficacy with excellent tolerance in a multi-center, Phase Ia study (AACR 2023)
    GQ1001 demonstrates an excellent tolerability and promising antitumor activity in heavily pretreated HER2-positive advanced solid tumors, supporting further evaluation of the safety and efficacy of GQ1001 at DRDE of 8.4 mg/kg in the following phase Ib trial.
    Clinical • P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    GQ1001
    over1year
    GQ1001 is a next generation HER2-targeting ADC with excellent druggability, safety and potency (AACR 2023)
    GQ1001 demonstrated similar in vitro anti-cancer activities to T-DM1 in HER2+ tumor cells. GQ1001 is a unique HER2-targeting ADC that exhibits markedly-enhanced linker stability and safety profiles. Judging from preclinical data, GQ1001 demonstrates the potential to treat HER2-positive cancer patients, alone or in combination, who have progressed on previous HER2-targeting therapeutics with reduced toxicity.
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    Kadcyla (ado-trastuzumab emtansine) • GQ1001
    2years
    GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=75, Active, not recruiting, Fudan University
    New P1/2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    capecitabine • Irene (pyrotinib) • GQ1001
    2years
    Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=96, Recruiting, GeneQuantum Healthcare (Suzhou) Co., Ltd. | N=27 --> 96 | Trial completion date: Dec 2021 --> May 2024 | Trial primary completion date: Dec 2021 --> Dec 2022
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    GQ1001
    over2years
    Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers. (PubMed, Front Mol Biosci)
    A third HER2-directed ADC, disitamab vedotin (RC48), has been approved for locally advanced or metastatic gastric or gastroesophageal junction cancer by the NMPA (National Medical Products Administration) of China in 2021. In this review article, we summarize the three approved ADCs (T-DM1, DS-8201a and RC48), together with the investigational EGFR-directed ADCs (ABT-414, MRG003 and M1231), HER2-directed ADCs (SYD985, ARX-788, A166, MRG002, ALT-P7, GQ1001 and SBT6050) and HER3-directed ADC (U3-1402). Lastly, we discuss the major challenges associated with the development of ADCs, and highlight the possible future directions to tackle these challenges.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ERBB4 (erb-b2 receptor tyrosine kinase 4)
    |
    HER-2 positive
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • patritumab deruxtecan (U3-1402) • Aidixi (disitamab vedotin) • anvatabart opadotin (JNJ-0683) • Jivadco (trastuzumab duocarmazine) • MRG003 • trastuzumab botidotin (A166) • pertuzumab zuvotolimod (SBT6050) • M1231 • depatuxizumab mafodotin (ABT-414) • trastuzumab vedotin (MRG002) • ALT-P7 • GQ1001
    3years
    Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=27, Recruiting, GeneQuantum Healthcare (Suzhou) Co., Ltd. | Trial primary completion date: Jun 2021 --> Dec 2021
    Clinical • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    GQ1001