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    BI 765063

    i
    Other names: BI 765063, Effi-DEM, OSE-172, BI-765063, BI765063, OSE 172, OSE172
    Associations

    News

    Trials
    Company:
    Boehringer Ingelheim, OSE Immunotherapeutics
    Drug class:
    SIRPA antagonist
    Related drugs:
    Associations

    News

    Trials
    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 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
    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
    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
    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 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
    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
    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 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 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
    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
    over1year
    Predictive response biomarkers from Phase I clinical trial of a SIRPalpha inhibitor BI765063, stand-alone and in combination with ezabenlimab, a PD1 inhibitor, in patients with advanced solid tumors (AACR 2023)
    High levels of CD11b+SIRPα+ myeloid cells in TME at baseline, but not CD47 tumor expression, correlates with longer survival while MDSC signature in TME at baseline correlates with clinical response. Thus, suggesting that MDSCs expressing SIRPα in TME could represent a predictive efficacy biomarker.
    Combination therapy • P1 data • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD47 (CD47 Molecule) • CD14 (CD14 Molecule) • CD68 (CD68 Molecule) • ITGAM (Integrin, alpha M) • SIRPA (Signal Regulatory Protein Alpha)
    |
    nCounter® PanCancer IO 360™ Panel
    |
    ezabenlimab (BI 754091) • BI 765063
    over2years
    A Study to Test How BI 765063 is Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov)
    P1, N=22, Recruiting, Boehringer Ingelheim | Trial completion date: Mar 2023 --> Jul 2024 | Trial primary completion date: Nov 2022 --> Nov 2023
    Trial completion date • Trial primary completion date
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    ezabenlimab (BI 754091) • BI 765063
    over2years
    A Study to Test Different Doses of BI 765063 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov)
    P1, N=18, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    ezabenlimab (BI 754091) • BI 765063
    over2years
    A Study to Test Different Doses of BI 765063 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Nov 2022 --> Apr 2022
    Trial completion date • Combination therapy
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    ezabenlimab (BI 754091) • BI 765063
    over2years
    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=150, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Erbitux (cetuximab) • Tecentriq (atezolizumab) • paclitaxel • docetaxel • capecitabine • ezabenlimab (BI 754091) • BI 765063 • BI 836880
    over2years
    Biomarker analyses from the Phase I clinical trial of the first-in-class SIRPa immune checkpoint inhibitor BI765063 in patients with advanced solid tumors (AACR 2022)
    This early biomarker analysis in patients with a wide range of solid tumors and treated with the first-in-class SIRPa inhibitor BI 765063 show encouraging signs of potentially mode-of-action related changes, both in peripheral blood and the TME. These early signals will be further evaluated in similar samples from the ongoing expansion cohorts in more homogeneous patient populations.
    Clinical • P1 data • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD14 (CD14 Molecule) • CD68 (CD68 Molecule) • CD40 (CD40 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    PD-L1 expression
    |
    BI 765063
    over2years
    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=150, Not yet recruiting, Boehringer Ingelheim
    New P1 trial • Combination therapy
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Erbitux (cetuximab) • Tecentriq (atezolizumab) • paclitaxel • docetaxel • capecitabine • ezabenlimab (BI 754091) • BI 765063 • BI 836880
    over2years
    A Study to Test Different Doses of BI 765063 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Boehringer Ingelheim | N=36 --> 18
    Enrollment change • Combination therapy
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    ezabenlimab (BI 754091) • BI 765063
    almost3years
    A Study to Test Different Doses of BI 765063 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov)
    P1, N=36, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    ezabenlimab (BI 754091) • BI 765063
    almost3years
    A Study to Test How BI 765063 is Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov)
    P1, N=22, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    ezabenlimab (BI 754091) • BI 765063
    3years
    A Study to Test How BI 765063 is Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov)
    P1, N=22, Not yet recruiting, Boehringer Ingelheim
    Clinical • New P1 trial
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    ezabenlimab (BI 754091) • BI 765063
    3years
    A Study to Test Different Doses of BI 765063 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov)
    P1, N=36, Recruiting, Boehringer Ingelheim | Trial completion date: Jun 2022 --> Nov 2022 | Trial primary completion date: Dec 2021 --> May 2022
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    ezabenlimab (BI 754091) • BI 765063