^
    6ms
    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)
    6ms
    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)
    8ms
    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)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    almost2years
    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)
    2years
    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)
    2years
    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)
    2years
    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)
    over2years
    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)
    P1a/1b, N=144, Recruiting, Boehringer Ingelheim | Trial completion date: Jun 2025 --> May 2026 | Trial primary completion date: Oct 2023 --> Sep 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    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)
    almost3years
    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 754111 or BI 907828 in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov)
    P1a/1b, N=144, Recruiting, Boehringer Ingelheim | Trial completion date: May 2024 --> Jun 2025 | Trial primary completion date: Sep 2022 --> Oct 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 mutation • BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • TP53 wild-type • ALK rearrangement
    |
    brigimadlin (BI 907828) • 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: May 2021 --> Nov 2022
    Clinical • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    3years
    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: Dec 2022 --> Sep 2022 | Trial primary completion date: Dec 2022 --> Aug 2022
    Clinical • 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)
    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 completion date: Nov 2021 --> Nov 2022 | Trial primary completion date: Oct 2021 --> May 2021
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    3years
    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 2021 --> Dec 2022 | Trial primary completion date: Aug 2021 --> Dec 2022
    Clinical • 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
    |
    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: May 2021 --> Nov 2021 | Trial primary completion date: Apr 2021 --> Oct 2021
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    almost4years
    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=145, Recruiting, Boehringer Ingelheim | Active, not recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    almost4years
    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 | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    4years
    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=173, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • 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
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    4years
    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=215, Recruiting, Boehringer Ingelheim | Trial completion date: Nov 2021 --> Aug 2021 | Trial primary completion date: Nov 2021 --> Aug 2021
    Clinical • 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
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over4years
    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 754111 or BI 907828 in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov)
    P1a/1b, N=170, Recruiting, Boehringer Ingelheim | Trial completion date: Aug 2023 --> May 2024 | Trial primary completion date: Dec 2021 --> Sep 2022
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 mutation • BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • ALK rearrangement
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over4years
    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=156, Recruiting, Boehringer Ingelheim | Suspended --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over4years
    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=215, Recruiting, Boehringer Ingelheim | Suspended --> Recruiting
    Clinical • Enrollment open • 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
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over4years
    [VIRTUAL] A phase I study of BI 754111, an anti-LAG-3 monoclonal antibody (mAb), in combination with BI 754091, an anti-PD-1 mAb: Biomarker analyses from the microsatellite stable metastatic colorectal cancer (MSS mCRC) cohort (AACR-II 2020)
    BI 754111 plus BI 754091 showed encouraging results in this IO-refractory MSS mCRC population. Biomarker analyses showed activation of the immune system in peripheral blood and the tumor, consistent with other CPIs.
    P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    PD-L1 expression • LAG3 expression
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over4years
    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 754111 or BI 907828 in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov)
    P1a/1b, N=170, Recruiting, Boehringer Ingelheim | Suspended --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • MDM2 (E3 ubiquitin protein ligase)
    |
    TP53 mutation • BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • ALK rearrangement
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over4years
    [VIRTUAL] A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 and BI 754111 in patients (pts) with advanced solid tumors. (ASCO 2020)
    Phase Ib will include at least 140 evaluable pts (80 pts in cohort 1 and 20 pts each in cohorts 2–4). Research Funding: Boehringer Ingelheim
    Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    over4years
    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=215, Suspended, Boehringer Ingelheim | Recruiting --> Suspended
    Clinical • Trial suspension • 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
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)
    almost5years
    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=215, Recruiting, Boehringer Ingelheim | Trial completion date: Feb 2021 --> Nov 2021 | Trial primary completion date: Feb 2021 --> Nov 2021
    Clinical • 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
    |
    ezabenlimab (BI 754091) • miptenalimab (BI 754111)