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    DRUG:

    D2C7

    i
    Other names: D2C7, D2C7 Immunotoxin, D2C7 IT, D2C7-IT
    Associations

    News

    Trials
    Company:
    Duke University, Istari Oncology
    Drug class:
    Elongation factor 2 inhibitor, EGFRvIII-targeted antibody-immunotoxin conjugate, EGFRwt-targeted antibody-immunotoxin conjugate
    Related drugs:
    Associations

    News

    Trials
    5ms
    D2C7-IT + 2141-V11 Combination Post-rection in rGBM - Phase 1b (clinicaltrials.gov)
    P1/2, N=46, Not yet recruiting, Darell Bigner
    New P1/2 trial
    |
    D2C7
    10ms
    Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma (clinicaltrials.gov)
    P1, N=30, Recruiting, Annick Desjardins, MD | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial primary completion date • Combination therapy
    |
    D2C7
    10ms
    D2C7-IT With Atezolizumab for Recurrent Gliomas (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Annick Desjardins, MD | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial primary completion date • Combination therapy
    |
    Tecentriq (atezolizumab) • D2C7
    1year
    Phase 1/1b trial of Fc-engineered Anti-CD40 Agonist Monoclonal Antibody (2141-V11) infused with D2C7-IT in enhancing disease by Convection-Enhanced Delivery (CED) for Recurrent Malignant Glioma (rMG) (SNO 2023)
    Eligibility includes adult patients with solitary supratentorial rMG (WHO grade 3/4); ≥ 4weeks after chemotherapy, bevacizumab, or investigational agent; adequate organ function; and KPS ≥70%. The RP2D for intratumoral infusion of D2C7-IT+2141-V11 via CED is identified. The protocol was amended to evaluate the addition of cervical perilymphatic injections of 2141-V11 post CED of D2C7-IT+2141-V11.
    P1 data • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • CD8 (cluster of differentiation 8)
    |
    EGFR mutation • EGFR wild-type
    |
    Avastin (bevacizumab) • D2C7
    1year
    D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients (clinicaltrials.gov)
    P1/2, N=50, Recruiting, Darell Bigner | Not yet recruiting --> Recruiting
    Enrollment open
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    RAS wild-type • IDH wild-type
    |
    D2C7
    over1year
    D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients (clinicaltrials.gov)
    P1/2, N=50, Not yet recruiting, Darell Bigner | Initiation date: May 2023 --> Aug 2023
    Trial initiation date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    RAS wild-type • IDH wild-type
    |
    D2C7
    over1year
    D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients (clinicaltrials.gov)
    P1/2, N=50, Not yet recruiting, Darell Bigner
    New P1/2 trial
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    RAS wild-type • IDH wild-type
    |
    D2C7
    almost2years
    Immunotoxin-αCD40 therapy activates innate and adaptive immunity and generates a durable antitumor response in glioblastoma models. (PubMed, Sci Transl Med)
    D2C7-IT+αCD40 treatment stimulated intratumoral CD8 T cell proliferation and generated cures in glioma-bearing mice despite FTY720-induced peripheral T cell sequestration. To determine potential translation, immunohistochemistry staining confirmed CD40 expression in human GBM tissue sections. These promising preclinical data allowed us to initiate a phase 1 study with D2C7-IT+αhCD40 in patients with malignant glioma (NCT04547777) to further evaluate this treatment in humans.
    Journal • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • CD8 (cluster of differentiation 8) • CD40 (CD40 Molecule)
    |
    EGFR mutation • EGFR wild-type • CD40 expression
    |
    fingolimod • D2C7
    over4years
    Improved efficacy against malignant brain tumors with EGFRwt/EGFRvIII targeting immunotoxin and checkpoint inhibitor combinations. (PubMed, J Immunother Cancer)
    These data support the development of D2C7-IT and immune checkpoint blockade combinations for patients with malignant glioma.
    Clinical • Journal • Checkpoint inhibition • PD(L)-1 Biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3) • CD73 (5'-Nucleotidase Ecto) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    EGFR mutation
    |
    D2C7