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    1m
    Targeting LAG3 to alter the tumor immune reactivity of CD8+T cells is a potential therapy for skin cutaneous melanoma. (PubMed, Sci Rep)
    Assay results demonstrated that both the LAG3 inhibitor ZYF0033 and the monoclonal antibody Miptenalimab significantly suppressed tumor proliferation and metastasis, while enhancing immune cell infiltration in murine models...Moreover, reduced LAG3 expression significantly enhanced CD8 + T cell immune infiltration, highlighting the regulatory role of LAG3 in CD8 + T cell function within the tumor microenvironment. These findings provided further evidence that SKCM may be effectively treated by targeting LAG3.
    Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    miptenalimab (BI 754111)
    11ms
    Platform Trial Evaluating Safety and Efficacy of BI 754091 Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours (clinicaltrials.gov)
    P2, N=212, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Dec 2024 | Trial primary completion date: May 2025 --> Dec 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    ezabenlimab (BI 754091) • BI 836880 • miptenalimab (BI 754111)
    over1year
    Platform Trial Evaluating Safety and Efficacy of BI 754091 Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours (clinicaltrials.gov)
    P2, N=212, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Jun 2024 --> May 2025 | Trial primary completion date: Jun 2024 --> May 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    ezabenlimab (BI 754091) • BI 836880 • miptenalimab (BI 754111)
    over1year
    A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov)
    P1, N=119, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 mutation • TP53 wild-type • TP53 amplification
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over1year
    A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov)
    P1, N=140, Recruiting, Boehringer Ingelheim | Phase classification: P1a/1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 mutation • TP53 wild-type • TP53 amplification
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over2years
    This Study Aims to Find a Safe and Effective Dose of BI 754091. The Study Also Aims to Find Safe and Effective Doses of BI 754091 and BI 754111 in Combination. This Study is Done in Asian Patients With Different Types of Cancer (clinicaltrials.gov)
    P1, N=146, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over2years
    This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment. (clinicaltrials.gov)
    P1, N=172, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
    |
    PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression • EGFR wild-type • ALK wild-type
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over2years
    Zr-immuno-PET using the anti-LAG-3 tracer [Zr]Zr-BI 754111: demonstrating target specific binding in NSCLC and HNSCC. (PubMed, Eur J Nucl Med Mol Imaging)
    [Zr]Zr-BI-754111 PET imaging shows favorable technical and biological characteristics for developing a potential predictive imaging biomarker for LAG-3-directed therapies.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    3years
    This Study Aims to Find a Safe and Effective Dose of BI 754091. The Study Also Aims to Find Safe and Effective Doses of BI 754091 and BI 754111 in Combination. This Study is Done in Asian Patients With Different Types of Cancer (clinicaltrials.gov)
    P1, N=146, Active, not recruiting, Boehringer Ingelheim | Trial primary completion date: Nov 2022 --> Aug 2023
    Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    3years
    PHASE IA/IB, DOSE-ESCALATION/EXPANSION STUDY OF THE MURINE DOUBLE MINUTE 2–TUMOR PROTEIN 53 ANTAGONIST BI 907828 IN COMBINATION WITH IMMUNE CHECKPOINT INHIBITORS IN PATIENTS WITH ADVANCED SOLID TUMORS (CTOS 2022)
    This Phase Ia/Ib study (NCT03964233) is assessing BI 907828, an MDM2–p53 antagonist, combined with immune checkpoint inhibitors in TP53 wild-type cancers. In Phase Ia (dose escalation), patients with advanced/metastatic solid tumors received escalating doses of BI 907828 guided by a Bayesian Logistic Regression Model (starting dose 10 mg orally) plus ezabenlimab 240 mg (anti-PD-1 antibody) and BI 754111 600 mg (anti-LAG-3 antibody) every 21 days (q3w). The doublet combination of BI 907828 plus ezabenlimab showed a manageable safety profile and early signs of anti-tumor activity. Eleven patients remain on treatment; recruitment is ongoing.
    P1 data • Preclinical • Combination therapy • Checkpoint inhibition
    |
    MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 wild-type
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over3years
    This Study Aims to Find a Safe and Effective Dose of BI 754091. The Study Also Aims to Find Safe and Effective Doses of BI 754091 and BI 754111 in Combination. This Study is Done in Asian Patients With Different Types of Cancer (clinicaltrials.gov)
    P1, N=146, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Nov 2022 --> Aug 2023
    Trial completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over3years
    This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment. (clinicaltrials.gov)
    P1, N=172, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Aug 2022 --> Jun 2023 | Trial primary completion date: Aug 2022 --> Jun 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
    |
    PD-L1 expression • TMB-H • MSI-H/dMMR • PD-L1 overexpression • EGFR wild-type • ALK wild-type
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)