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    DRUG:

    M1231

    i
    Other names: M1231, MUC1-EGFR bispecific antibody drug conjugate
    Company:
    EMD Serono, Sutro Biopharma
    Drug class:
    Microtubule inhibitor, EGFR-targeted antibody-drug conjugate, MUC1-targeted antibody-drug conjugate
    Related drugs:
    10ms
    M1231 in Participants With Solid Tumors (clinicaltrials.gov)
    P1, N=23, Completed, EMD Serono Research & Development Institute, Inc. | Active, not recruiting --> Completed | N=84 --> 23 | Trial completion date: Mar 2024 --> Jun 2023
    Trial completion • Enrollment change • Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability) • MUC1 (Mucin 1)
    |
    MSI-H/dMMR • EGFR expression • MUC1 expression • MUC1 expression + EGFR expression
    |
    M1231
    over1year
    M1231 in Participants With Solid Tumors (clinicaltrials.gov)
    P1, N=84, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability) • MUC1 (Mucin 1)
    |
    MSI-H/dMMR • EGFR expression • MUC1 expression
    |
    M1231
    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
    2years
    Translational PK/PD/efficacy modeling and efficacious human dose prediction for a first-in-class MUC1-EGFR (M1231) bispecific antibody drug conjugate (AACR 2022)
    The quantitative systems pharmacology model-based efficacious dose prediction range of 2.4 mg/kg to 4.3 mg/kg dosed Q3W informed the design of the ongoing M1231 first-in-human trial (NCT04695847).
    Clinical • PK/PD data
    |
    EGFR (Epidermal growth factor receptor) • MUC1 (Mucin 1)
    |
    EGFR expression • MUC1 expression
    |
    M1231
    3years
    M1231 in Participants With Solid Tumors (clinicaltrials.gov)
    P1, N=84, Recruiting, EMD Serono Research & Development Institute, Inc. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability) • MUC1 (Mucin 1)
    |
    MSI-H/dMMR • EGFR expression • MUC1 expression
    |
    M1231
    over3years
    M1231 in Participants With Solid Tumors (clinicaltrials.gov)
    P1, N=84, Not yet recruiting, EMD Serono Research & Development Institute, Inc.
    Clinical • New P1 trial
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability) • MUC1 (Mucin 1)
    |
    MSI-H/dMMR • EGFR expression • MUC1 expression
    |
    M1231