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    DRUG:

    brigimadlin (BI 907828)

    i
    Other names: BI 907828, BI-907828, BI907828
    Company:
    Boehringer Ingelheim
    Drug class:
    MDM2-p53 antagonist
    21d
    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)
    27d
    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)
    1m
    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)
    1m
    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)
    1m
    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)
    2ms
    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)
    |
    TP53 mutation • TP53 wild-type
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    2ms
    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
    |
    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)
    2ms
    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)
    4ms
    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)
    4ms
    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)
    6ms
    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)
    6ms
    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)