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    DRUG:

    BI-1607

    i
    Other names: BI-1607
    Associations

    News

    Trials
    Company:
    BioInvent
    Drug class:
    Fcγ receptor IIB antagonist
    Related drugs:
    Associations

    News

    Trials
    3ms
    KEYNOTE-G05: Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P1/2, N=35, Active, not recruiting, BioInvent International AB | Recruiting --> Active, not recruiting | Trial completion date: Jun 2031 --> Dec 2025 | Trial primary completion date: Sep 2028 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • BI-1607
    5ms
    A First-in-Class Monoclonal Antibody (BI-1607) Targeting FcγRIIB: Preclinical Data and First-in-Human Studies in Patients with HER2-Positive Advanced Solid Tumors. (PubMed, Clin Cancer Res)
    The enhancing effect on tumor direct-targeting antibodies observed preclinically, together with the favorable safety profile in patients support further investigation of BI-1607.
    P1 data • Preclinical • Journal • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • BI-1607
    1year
    Different Doses of BI-1607 in Combination with Pembrolizumab and Ipilimumab, in Participants with Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P1/2, N=35, Recruiting, BioInvent International AB
    New P1/2 trial
    |
    PD-1 (Programmed cell death 1) • FCGR2A (Fc fragment of IgG receptor IIa)
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • BI-1607
    1year
    CONTRAST: BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=18, Terminated, BioInvent International AB | Active, not recruiting --> Terminated; After the completion of phase IA, for business reasons it was decided to terminate the study.
    Trial termination • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab) • BI-1607
    2years
    CONTRAST: BI-1607 in Combination With Trastuzumab in Subjects With HER2-positive Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=18, Active, not recruiting, BioInvent International AB | Recruiting --> Active, not recruiting | N=116 --> 18 | Trial completion date: Dec 2026 --> Apr 2024 | Trial primary completion date: Mar 2025 --> Feb 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab) • BI-1607
    over2years
    Phase 1/2a Open-label Clinical Trial of BI-1607, an Fc Engineered Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors – CONTRAST (SABCS 2023)
    This concept was demonstrated in preclinical in vivo models showing increased efficacy of the combination therapy with the murine surrogate of BI-1607 and an anti-HER2, an anti–cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), and an anti-CD20 (rituximab) as compared to monotherapy...The choice of trastuzumab as the combination agent in this trial was based on promising preclinical studies, a recognized need for additional options for those patients who fail to respond or stop responding to trastuzumab, and promising results from the newly approved Fc-engineered anti-HER2 mAb margetuximab...Phase 2a will enroll 15 subjects each in two cohorts of HER2+ advanced/metastatic breast cancer or HER2+ gastric/GEJ adenocarcinoma respectively. For information regarding the study, please contact: anna.ropenga@bioinvent.com
    Clinical • P1/2 data • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    HER-2 positive • EGFR positive
    |
    Herceptin (trastuzumab) • Rituxan (rituximab) • Margenza (margetuximab-cmkb) • BI-1607
    over3years
    CONTRAST: BI-1607 in Combination With Trastuzumab in Subjects With HER2-positive Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=116, Recruiting, BioInvent International AB
    New P1/2 trial • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab) • BI-1607