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    DRUG:

    JNJ-6358

    i
    Other names: JNJ-6358, JNJ 78306358, JNJ-78306358
    Associations

    News

    Trials
    Company:
    J&J, Zymeworks
    Drug class:
    CD3 agonist, HLA G inhibitor
    Related drugs:
    Associations

    News

    Trials
    3ms
    Safety and clinical activity of JNJ-78306358, a human leukocyte antigen-G (HLA-G) x CD3 bispecific antibody, for the treatment of advanced stage solid tumors. (PubMed, Cancer Immunol Immunother)
    JNJ-78306358 showed pharmacodynamic effects with induction of cytokines and T cell activation. JNJ-78306358 was associated with CRS-related toxicities including increased transaminases and pneumonitis which limited its dose escalation to potentially efficacious levels. Trial registration number ClinicalTrials.gov (No. NCT04991740).
    Journal • Metastases
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    HLA-G (Major Histocompatibility Complex, Class I, G)
    |
    Actemra IV (tocilizumab) • JNJ-6358
    over1year
    Safety and preliminary clinical activity of JNJ-78306358 (JNJ-358), an HLA-G and CD3 bispecific antibody, for the treatment of advanced stage solid tumor (ESMO 2023)
    CRS was G1 or G2 and responded to tocilizumab. Considering the CRS-related toxicities and the ADA formation, the Sponsor decided to halt dose escalation. No recommended phase 2 dose was determined.
    Clinical • Metastases
    |
    HLA-G (Major Histocompatibility Complex, Class I, G)
    |
    Actemra IV (tocilizumab) • JNJ-6358
    over1year
    A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov)
    P1, N=39, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Feb 2023 | Trial primary completion date: Feb 2024 --> Feb 2023
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    JNJ-6358
    almost2years
    A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov)
    P1, N=39, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting | N=140 --> 39
    Enrollment closed • Enrollment change • Metastases
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    JNJ-6358
    2years
    A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov)
    P1, N=140, Recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2024 --> Jan 2025
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    JNJ-6358
    over2years
    A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov)
    P1, N=140, Recruiting, Janssen Research & Development, LLC | Trial completion date: Apr 2024 --> Aug 2024
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    JNJ-6358
    almost3years
    A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov)
    P1, N=140, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    JNJ-6358
    over3years
    A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors (clinicaltrials.gov)
    P1, N=140, Not yet recruiting, Janssen Research & Development, LLC
    New P1 trial
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    JNJ-6358