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    DRUG:

    MRG003

    i
    Other names: MRG003
    Company:
    Lepu Med
    Drug class:
    Microtubule inhibitor, EGFR-targeted antibody-drug conjugate
    Related drugs:
    over1year
    A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=18, Recruiting, Shanghai Miracogen Inc.
    New P1/2 trial • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR positive
    |
    Puyouheng (pucotenlimab) • MRG003
    over1year
    MRG003, a Novel EGFR Targeted ADC for Recurrent/ Metastatic Nasopharyngeal Carcinoma (ADC London 2023)
    • Discover MRG003, is a novel EGFR targeted ADC • Outlining Phase II clinical study design in NPC • Encouraging efficacy observed in recurrent and metastatic NPC patients with manageable safety • Discussing Breakthrough Treatment Designation (BTD) granted by NMPA to MRG003 for NPC
    Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    MRG003
    almost2years
    Evaluation of Safety of Treatment With Anti-Epidermal Growth Factor Receptor Antibody Drug Conjugate MRG003 in Patients With Advanced Solid Tumors: A Phase 1 Nonrandomized Clinical Trial. (PubMed, JAMA Oncol)
    The findings of this nonrandomized clinical trial suggest that MRG003 showed a manageable safety profile and promising antitumor activity in patients with EGFR-positive NPC and SCCHN. Clinicaltrials.gov Identifier: NCT04868344.
    Clinical • P1 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression • EGFR positive
    |
    MRG003
    2years
    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
    over2years
    A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer. (clinicaltrials.gov)
    P2, N=60, Recruiting, Shanghai Miracogen Inc.
    Clinical • New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    MRG003
    over2years
    A Study of MRG003 in the Treatment of EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Shanghai Miracogen Inc. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    EGFR (Epidermal growth factor receptor)
    |
    MRG003
    3years
    A Study of MRG003 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=61, Completed, Shanghai Miracogen Inc.
    Clinical • New P1 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR positive
    |
    MRG003
    3years
    A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=90, Recruiting, Shanghai Miracogen Inc.
    Clinical • New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression • EGFR positive
    |
    MRG003
    3years
    A Study of MRG003 in the Treatment of EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Shanghai Miracogen Inc.
    Clinical • New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR positive
    |
    MRG003