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    DRUG CLASS:

    MUC1-targeted antibody-drug conjugate

    Related drugs:
    11ms
    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
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    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability) • MUC1 (Mucin 1)
    |
    MSI-H/dMMR • EGFR expression • MUC1 expression • MUC1 expression + EGFR expression
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    M1231
    1year
    A first-in-class bispecific antibody-drug conjugate (DM002) targeting HER3 and the juxtamembrane domain of MUC1 (AACR 2023)
    DM002 candidates showed robust anti-tumor activity in multiple CDX and PDX models of lung, breast, gastric and pancreatic cancer; most notably, DM002 candidates outperformed benchmark ADCs in BP0508 lung PDX models. Together, these data indicate that DM002 will be a promising therapeutic drug for patients with HER3 and MUC1 co-expressing tumors.
    Late-breaking abstract
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    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • MUC1 (Mucin 1)
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    ERBB3 expression • MUC1 expression
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    DM002 • R3Mab
    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
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    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
    over3years
    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