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    DRUG CLASS:

    MDM2-p53 antagonist

    Related drugs:
    8d
    This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov)
    P1, N=266, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 wild-type
    |
    brigimadlin (BI 907828)
    2ms
    A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine (clinicaltrials.gov)
    P2, N=90, Recruiting, Boehringer Ingelheim | N=50 --> 90
    Enrollment change
    |
    brigimadlin (BI 907828)
    2ms
    Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder (clinicaltrials.gov)
    P2, N=99, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 wild-type
    |
    brigimadlin (BI 907828)
    3ms
    EMPIRE: Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures (clinicaltrials.gov)
    P2, N=0, Withdrawn, Institut Bergonié | N=120 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
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    PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53)
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    TP53 wild-type
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    brigimadlin (BI 907828) • ezabenlimab (BI 754091)
    4ms
    MDM2-GPX4-ferroptosis regulatory axis exerts neurotoxic effects in intracerebral hemorrhage. (PubMed, Neural Regen Res)
    Furthermore, intracerebral hemorrhage mouse models were constructed with and without an murine double minute 2 inhibitor (brigimadlin), and behavioral assays were performed to assess the learning ability and cognitive function...This regulation promotes ferroptosis and inflammatory responses in oxygen-glucose deprivation combined with hemin-induced BV2 microglial cells, suggesting that the murine double minute 2-glutathione peroxidase 4-ferroptosis regulatory axis exerts neurotoxic effects. These findings identify glutathione peroxidase 4 as a potential gene therapy target for intracerebral hemorrhage-related brain injury.
    Journal
    |
    WT1 (WT1 Transcription Factor) • GPX4 (Glutathione Peroxidase 4)
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    brigimadlin (BI 907828)
    4ms
    A Study to Determine How BI 907828 (Brigimadlin) is Taken up in the Tumor (Phase 0) and to Determine the Highest Dose of BI 907828 (Brigimadlin) That Could be Tolerated (Phase 1a) in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma (clinicaltrials.gov)
    P1, N=24, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    TP53 (Tumor protein P53)
    |
    TP53 wild-type • IDH wild-type
    |
    brigimadlin (BI 907828)
    5ms
    Brigimadlin (BI-907828) and napabucasin (BBI608) cooperatively trigger apoptosis in chronic lymphocytic leukemia cells by simultaneous iİnhibition of MDM2 and STAT3. (PubMed, Mol Biol Rep)
    These findings establish a mechanistic rationale for the concurrent targeting of the MDM2 and STAT3 axes and provide preclinical evidence for a promising, non-genotoxic therapeutic strategy in p53-functional CLL. A limitation of this study is the lack of in vivo validation and clinical data, which are necessary to further assess the safety, optimal dosing, and efficacy, particularly in elderly or unfit patients with limited treatment options.
    Journal • PARP Biomarker
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    STAT3 (Signal Transducer And Activator Of Transcription 3) • CASP3 (Caspase 3) • CASP7 (Caspase 7) • CDKN1A (Cyclin-dependent kinase inhibitor 1A)
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    TP53 mutation • TP53 wild-type
    |
    brigimadlin (BI 907828) • napabucasin (BBI608)
    5ms
    Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder (clinicaltrials.gov)
    P2, N=99, Active, not recruiting, Boehringer Ingelheim | Trial primary completion date: Jun 2025 --> Oct 2025
    Trial primary completion date
    |
    TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 wild-type
    |
    brigimadlin (BI 907828)
    7ms
    A Study in People With Advanced Cancer to Test Whether the Amount of BI 907828 in the Blood is Influenced by Taking an OATP Inhibitor or a CYP3 Inhibitor (clinicaltrials.gov)
    P1, N=33, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    TP53 (Tumor protein P53)
    |
    TP53 wild-type
    |
    brigimadlin (BI 907828) • itraconazole • rifampicin
    7ms
    A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine (clinicaltrials.gov)
    P2, N=50, Recruiting, Boehringer Ingelheim | Trial completion date: Dec 2036 --> Dec 2030 | Trial primary completion date: Dec 2036 --> Dec 2030
    Trial completion date • Trial primary completion date
    |
    brigimadlin (BI 907828)
    8ms
    Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder (clinicaltrials.gov)
    P2, N=99, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Jun 2025 --> Oct 2025
    Trial completion date
    |
    TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 wild-type
    |
    brigimadlin (BI 907828)
    9ms
    Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma (clinicaltrials.gov)
    P2/3, N=401, Active, not recruiting, Boehringer Ingelheim | Trial completion date: May 2026 --> Nov 2025
    Trial completion date
    |
    MDM2 (E3 ubiquitin protein ligase)
    |
    doxorubicin hydrochloride • brigimadlin (BI 907828)