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    DRUG CLASS:

    MDM2-p53 antagonist

    Related drugs:
    9d
    Brigimadlin Versus Doxorubicin in Advanced Dedifferentiated Liposarcoma: Efficacy, Safety and Translational Data from Brightline-1, a Randomized Phase 2/3 Trial. (PubMed, Clin Cancer Res)
    While brigimadlin showed activity in this patient population, the median PFS with doxorubicin was substantially longer than anticipated and the primary endpoint of PFS was not met. The safety profile of brigimadlin also did not appear to be more manageable than that of doxorubicin. The translational results will guide future clinical investigations of MDM2-p53 antagonists.
    P2/3 data • Journal
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    MDM2 (E3 ubiquitin protein ligase)
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    doxorubicin hydrochloride • brigimadlin (BI 907828)
    1m
    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, Terminated, Boehringer Ingelheim | Completed --> Terminated; Sponsor decision
    Trial termination
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    TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
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    TP53 wild-type
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    brigimadlin (BI 907828)
    3ms
    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, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting | N=31 --> 90
    Enrollment closed • Enrollment change
    |
    brigimadlin (BI 907828)
    3ms
    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=31, Recruiting, Boehringer Ingelheim | Active, not recruiting --> Recruiting
    Enrollment open
    |
    brigimadlin (BI 907828)
    3ms
    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, Active, not recruiting, Boehringer Ingelheim | N=31 --> 90
    Enrollment change
    |
    brigimadlin (BI 907828)
    4ms
    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=31, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    brigimadlin (BI 907828)
    4ms
    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=400, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    MDM2 (E3 ubiquitin protein ligase)
    |
    doxorubicin hydrochloride • brigimadlin (BI 907828)
    4ms
    A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov)
    P1, N=119, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
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    TP53 mutation • TP53 wild-type
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    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    4ms
    Pharmacokinetic-pharmacodynamic-efficacy modeling of the MDM2 inhibitor brigimadlin in glioblastoma patient-derived xenografts. (PubMed, Neurooncol Adv)
    Brigimadlin is highly effective in MDM2-amplified GBM when adequate drug levels are achieved in tumor tissue. MDM2 amplification impacts both treatment efficacy and intratumoral drug accumulation.
    PK/PD data • Journal
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    MDM2 (E3 ubiquitin protein ligase) • ABCG2 (ATP Binding Cassette Subfamily G Member 2) • RAG1 (Recombination Activating 1)
    |
    TP53 wild-type • IDH wild-type
    |
    brigimadlin (BI 907828)
    4ms
    A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov)
    P1, N=119, Active, not recruiting, Boehringer Ingelheim | Trial completion date: May 2026 --> Feb 2026
    Trial completion date
    |
    TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 mutation • TP53 wild-type
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    6ms
    Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma (clinicaltrials.gov)
    P3, N=138, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    MDM2 (E3 ubiquitin protein ligase)
    |
    brigimadlin (BI 907828)
    7ms
    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)