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    DRUG:

    ezabenlimab (BI 754091)

    i
    Other names: BI 754091, BI754091, BI-754091
    Company:
    Boehringer Ingelheim
    Drug class:
    PD1 inhibitor
    Related drugs:
    25d
    A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Expressing the Protein B7-H6 on the Cell Surface (clinicaltrials.gov)
    P1, N=67, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting | N=248 --> 67
    Enrollment closed • Enrollment change • Metastases
    |
    NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    ezabenlimab (BI 754091) • BI 765049
    2ms
    A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (clinicaltrials.gov)
    P1, N=252, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    ezabenlimab (BI 754091) • BI 836880
    3ms
    A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer (clinicaltrials.gov)
    P1, N=160, Recruiting, Boehringer Ingelheim | Trial completion date: Jan 2027 --> Nov 2028 | Trial primary completion date: Apr 2026 --> Aug 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • ezabenlimab (BI 754091) • BI 765179
    3ms
    A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov)
    P1, N=13, Recruiting, Boehringer Ingelheim | Trial completion date: May 2025 --> Aug 2025 | Trial primary completion date: Mar 2025 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    ezabenlimab (BI 754091) • BI 765063 • BI 770371
    4ms
    A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Expressing the Protein B7-H6 on the Cell Surface (clinicaltrials.gov)
    P1, N=248, Recruiting, Boehringer Ingelheim | N=120 --> 248
    Enrollment change • Metastases
    |
    NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    ezabenlimab (BI 754091) • BI 765049
    4ms
    A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated (clinicaltrials.gov)
    P1, N=36, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    ezabenlimab (BI 754091) • BI 770371
    4ms
    A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov)
    P1, N=48, Active, not recruiting, Boehringer Ingelheim | Trial primary completion date: Nov 2024 --> Jul 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Erbitux (cetuximab) • paclitaxel • docetaxel • capecitabine • ezabenlimab (BI 754091) • BI 765063 • BI 836880
    4ms
    A Study to Test How Well Different Doses of BI 764532 in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3 (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Boehringer Ingelheim | N=30 --> 42 | Trial completion date: Feb 2025 --> Jun 2025 | Trial primary completion date: Feb 2025 --> Jun 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    obrixtamig (BI 764532) • ezabenlimab (BI 754091)
    4ms
    Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
    P3, N=0, Withdrawn, Boehringer Ingelheim | N=263 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy • Metastases
    |
    gemcitabine • docetaxel • brigimadlin (BI 907828) • ezabenlimab (BI 754091)
    4ms
    BI-754091 and Afatinib for Refractory Esophageal Squamous Cell Carcinoma (BEAR Study) (clinicaltrials.gov)
    P2, N=49, Completed, National Health Research Institutes, Taiwan | Enrolling by invitation --> Completed | Trial completion date: May 2023 --> Jun 2024
    Trial completion • Trial completion date
    |
    Gilotrif (afatinib) • ezabenlimab (BI 754091)
    6ms
    A Study to Test Different Doses of BI 1831169 Alone and in Combination With Ezabenlimab in People With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov)
    P1, N=190, Recruiting, Boehringer Ingelheim | N=117 --> 190
    Enrollment change • Combination therapy • Metastases
    |
    ezabenlimab (BI 754091) • BI 1831169
    6ms
    A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov)
    P1, N=13, Recruiting, Boehringer Ingelheim | Trial completion date: Oct 2024 --> Mar 2025 | Trial primary completion date: Jul 2024 --> Jan 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    ezabenlimab (BI 754091) • BI 765063 • BI 770371
    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)
    7ms
    A Study to Test Different Doses of BI 1831169 Alone and in Combination With Ezabenlimab in People With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov)
    P1, N=117, Recruiting, Boehringer Ingelheim | Trial primary completion date: Nov 2025 --> May 2027 | Trial completion date: Nov 2026 --> May 2028
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    ezabenlimab (BI 754091) • BI 1831169
    7ms
    A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov)
    P1, N=48, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2025 --> Nov 2024
    Enrollment closed • Trial primary completion date • Combination therapy • Metastases
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Erbitux (cetuximab) • paclitaxel • docetaxel • capecitabine • ezabenlimab (BI 754091) • BI 765063 • BI 836880
    7ms
    Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
    P3, N=263, Not yet recruiting, Boehringer Ingelheim
    New P3 trial • Combination therapy • Metastases
    |
    gemcitabine • docetaxel • brigimadlin (BI 907828) • ezabenlimab (BI 754091)
    7ms
    A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated (clinicaltrials.gov)
    P1, N=42, Recruiting, Boehringer Ingelheim | Trial completion date: Nov 2025 --> Jan 2025 | Trial primary completion date: Mar 2025 --> Jul 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    ezabenlimab (BI 754091) • BI 770371
    7ms
    A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov)
    P1, N=45, Recruiting, Boehringer Ingelheim | Active, not recruiting --> Recruiting | Trial primary completion date: Aug 2024 --> Apr 2025
    Enrollment open • Trial primary completion date • Combination therapy • Metastases
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Erbitux (cetuximab) • Tecentriq (atezolizumab) • paclitaxel • docetaxel • capecitabine • ezabenlimab (BI 754091) • BI 765063 • BI 836880
    8ms
    A Study to Find the Best Dose of BI 1387446 Alone or in Combination With Ezabenlimab (BI 754091) in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors) (clinicaltrials.gov)
    P1, N=39, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    ezabenlimab (BI 754091) • BI 1387446
    8ms
    CAR2BRAIN: Intracranial Injection of NK-92/5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma (clinicaltrials.gov)
    P1, N=42, Active, not recruiting, Johann Wolfgang Goethe University Hospital | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Jun 2026 | Trial primary completion date: Oct 2023 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    ezabenlimab (BI 754091) • HER2 t-haNK
    8ms
    A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov)
    P1, N=47, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Erbitux (cetuximab) • Tecentriq (atezolizumab) • paclitaxel • docetaxel • capecitabine • ezabenlimab (BI 754091) • BI 765063 • BI 836880
    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)
    9ms
    A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Having the B7-H6 Marker (clinicaltrials.gov)
    P1, N=120, Recruiting, Boehringer Ingelheim | Trial completion date: May 2025 --> Dec 2028 | Trial primary completion date: May 2025 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    ezabenlimab (BI 754091) • BI 765049
    10ms
    A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov)
    P1, N=70, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open
    |
    NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    ezabenlimab (BI 754091) • BI 765049
    10ms
    KISIMA-01: Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer (clinicaltrials.gov)
    P1, N=96, Active, not recruiting, Amal Therapeutics | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ezabenlimab (BI 754091)
    10ms
    A Study to Test How Well Different Doses of BI 764532 in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3 (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Boehringer Ingelheim | Trial completion date: Oct 2024 --> Feb 2025 | Trial primary completion date: Oct 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    obrixtamig (BI 764532) • ezabenlimab (BI 754091)
    11ms
    A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery (clinicaltrials.gov)
    P1, N=2, Terminated, Boehringer Ingelheim | Completed --> Terminated; Company decision
    Trial termination • Adverse events • Combination therapy • Surgery
    |
    Keytruda (pembrolizumab) • ezabenlimab (BI 754091) • BI 765063
    11ms
    A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) (clinicaltrials.gov)
    P1, N=160, Recruiting, Boehringer Ingelheim | Trial completion date: Mar 2026 --> Nov 2026 | Trial primary completion date: Jun 2025 --> Feb 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    ezabenlimab (BI 754091) • BI 765179
    11ms
    INTERACT-ION: Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma. (clinicaltrials.gov)
    P2, N=55, Active, not recruiting, Centre Hospitalier Universitaire de Besancon | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • docetaxel • 5-fluorouracil • ezabenlimab (BI 754091)
    12ms
    A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Having the B7-H6 Marker (clinicaltrials.gov)
    P1, N=120, Recruiting, Boehringer Ingelheim | Trial primary completion date: Nov 2023 --> May 2025
    Trial primary completion date
    |
    NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    ezabenlimab (BI 754091) • BI 765049
    12ms
    A Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02) (clinicaltrials.gov)
    P1, N=85, Recruiting, Amal Therapeutics | Phase classification: P1b --> P1
    Phase classification
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12V • KRAS G12
    |
    ezabenlimab (BI 754091) • ATP150 • ATP152 • VSV-GP154
    12ms
    A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov)
    P1, N=45, Recruiting, Boehringer Ingelheim | N=150 --> 45
    Enrollment change
    |
    Erbitux (cetuximab) • Tecentriq (atezolizumab) • paclitaxel • docetaxel • capecitabine • ezabenlimab (BI 754091) • BI 765063 • BI 836880
    12ms
    A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov)
    P1, N=70, Not yet recruiting, Boehringer Ingelheim | Trial completion date: Jan 2026 --> Mar 2027 | Trial primary completion date: Nov 2025 --> Dec 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    ezabenlimab (BI 754091) • BI 765049
    12ms
    A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery (clinicaltrials.gov)
    P1, N=2, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion • Adverse events • Combination therapy • Surgery
    |
    Keytruda (pembrolizumab) • ezabenlimab (BI 754091) • BI 765063
    1year
    A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov)
    P1, N=70, Not yet recruiting, Boehringer Ingelheim | Initiation date: Oct 2023 --> Feb 2024
    Trial initiation date • Combination therapy • Metastases
    |
    NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    ezabenlimab (BI 754091) • BI 765049
    1year
    A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov)
    P1, N=12, Recruiting, Boehringer Ingelheim | N=22 --> 12 | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Apr 2024
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    ezabenlimab (BI 754091) • BI 765063 • BI 770371
    1year
    A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov)
    P1, N=70, Not yet recruiting, Boehringer Ingelheim
    New P1 trial • Combination therapy • Metastases
    |
    NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    ezabenlimab (BI 754091) • BI 765049
    1year
    EMPIRE: Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Institut Bergonié
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53)
    |
    TP53 wild-type
    |
    brigimadlin (BI 907828) • ezabenlimab (BI 754091)
    1year
    Neoadjuvant ezabenlimab or pembrolizumab in combination with an anti-SIRPα antibody in resectable colorectal cancer (SITC 2023)
    Methods This phase I, open-label, parallel-cohort, single-center trial (NCT05446129) was designed to assess the safety, feasibility, clinical efficacy, and biological activity of BI-765063 (an anti-SIRPα antibody) in combination with either ezabenlimab (Cohort A) or pembrolizumab (Cohort B), both anti-PD-1 antibodies, in patients with early-stage, resectable CRC (figure 1). Tissue, blood, and stool will be collected prior to treatment administration and at the time of resection. Immune monitoring will be performed using multiplex and single-cell analysis platforms to define the immunodynamic effects of these therapies.
    Clinical • Combination therapy
    |
    CD47 (CD47 Molecule) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • SIRPA (Signal Regulatory Protein Alpha)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • ezabenlimab (BI 754091) • BI 765063
    1year
    A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours (clinicaltrials.gov)
    P1, N=112, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    ezabenlimab (BI 754091)
    over1year
    A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Having the B7-H6 Marker (clinicaltrials.gov)
    P1, N=120, Recruiting, Boehringer Ingelheim | Trial completion date: Dec 2024 --> May 2025
    Trial completion date • Metastases
    |
    NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    ezabenlimab (BI 754091) • BI 765049