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    DRUG:

    IBI-389

    i
    Other names: IBI-389, IBI389, IBI 389
    Associations

    News

    Trials
    Company:
    Innovent Biologics
    Drug class:
    CD3 agonist, CLDN18.2 inhibitor
    Related drugs:
    Associations

    News

    Trials
    9d
    The claudin-18.2-CD3 bispecific antibody IBI389 exerts an antitumor effect on malignant tumors with positive claudin-18.2 expression by promoting T-cell infiltration and remodeling the tumor immune microenvironment. (PubMed, Transl Cancer Res)
    In this study, we demonstrated that IBI389 effectively redirects T cells to CLDN18.2-expressing tumors, suppresses tumor growth, and synergizes with PD-1 blockade and has a favorable safety profile. By virtue of its ability to enhance immune infiltration, remodel cytokine responses, and reduce tumor-immune spatial separation, IBI389 may have considerable potential as a novel therapeutic strategy for CLDN18.2-positive gastric cancer and related malignancies.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CLDN18 (Claudin 18) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10) • IL17A (Interleukin 17A) • IL4 (Interleukin 4)
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    CLDN18.2 expression • CLDN18.2 positive • CLDN1 positive
    |
    IBI-389
    3ms
    Safety and preliminary efficacy results of IBI389, an anti-Claudin18.2×CD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: a phase 1 dose escalation and expansion study. (PubMed, BMC Med)
    IBI389 showed manageable safety profiles in patients with advanced solid tumors and preliminary efficacy in Claudin18.2-positive patients with GC/GEJC.
    P1 data • Journal
    |
    CLDN18 (Claudin 18)
    |
    IBI-389
    over2years
    Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, in Patients With Advanced Malignancies (clinicaltrials.gov)
    P1, N=320, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Phase classification: P1a/1b --> P1 | Trial completion date: Apr 2024 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
    Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    Tyvyt (sintilimab) • IBI-389
    over2years
    Safety, tolerability and preliminary efficacy of IBI389 in subjects with advanced pancreatic cancer: An open-label phase II study (ChiCTR2300077565 )
    P2, N=42, Not yet recruiting, First Affiliated Hospital of Anhui Medical University
    New P2 trial • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    gemcitabine • albumin-bound paclitaxel • IBI-389
    over3years
    Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, in Patients With Advanced Malignancies (clinicaltrials.gov)
    P1a/1b, N=320, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    Tyvyt (sintilimab) • IBI-389
    over4years
    Safety and Efficacy of IBI389 Single Agent and in Combination With Sintilimab in Patients With Advanced Malignancies (clinicaltrials.gov)
    P1a/1b, N=320, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    Clinical • New P1 trial • Combination therapy
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression
    |
    Tyvyt (sintilimab) • IBI-389