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    BI 836880

    i
    Other names: BI 836880, BI-836880, VEGF/Ang2, anti-VEGF/Ang2 Nanobody, bi-specific Anti-VEGF/Ang2 Nanobody, BI836880
    Associations

    News

    Trials
    Company:
    Boehringer Ingelheim
    Drug class:
    VEGF inhibitor, Angiopoietin 2 inhibitor
    Related drugs:
    Associations

    News

    Trials
    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
    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
    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)
    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
    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
    1year
    A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD) (clinicaltrials.gov)
    P1/2, N=43, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    BI 836880
    over1year
    Preclinical evaluation of the VEGF/Ang2 bispecific nanobody BI 836880 in nasopharyngeal carcinoma models. (PubMed, Invest New Drugs)
    When compared with bevacizumab, BI 836880 appeared to show at least comparable activity as bevacizumab in terms of its anti-proliferative and anti-angiogenic effects. This study showed that BI 836880 has anti-proliferative, anti-angiogenic and possibly immunomodulatory effect in clinical models of NPC, therefore the dual targeting of VEGF and Ang2 signaling in NPC should be further investigated.
    Preclinical • Journal
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    VEGFA (Vascular endothelial growth factor A) • HIF1A (Hypoxia inducible factor 1, alpha subunit)
    |
    VEGFA overexpression • VEGFA expression
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    Avastin (bevacizumab) • BI 836880
    over1year
    Phase I study of the VEGF/Ang-2 inhibitor BI 836880 alone or combined with the anti-programmed cell death protein-1 antibody ezabenlimab in Japanese patients with advanced solid tumors. (PubMed, Cancer Chemother Pharmacol)
    MTD was not reached. BI 836880 alone and in combination with ezabenlimab had a manageable safety profile with preliminary clinical activity in Japanese patients with advanced solid tumors.
    P1 data • Clinical Trial,Phase I • Journal • Metastases
    |
    ezabenlimab (BI 754091) • BI 836880
    over2years
    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, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Jan 2025 --> Aug 2024 | Trial primary completion date: Jan 2025 --> Aug 2024
    Trial completion date • Trial primary completion date • Combination therapy • PD(L)-1 companion diagnostic
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    ezabenlimab (BI 754091) • BI 836880
    over2years
    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, Active, not recruiting, Boehringer Ingelheim | Trial primary completion date: Feb 2022 --> Jan 2025
    Trial primary completion date • Combination therapy • PD(L)-1 companion diagnostic
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    ezabenlimab (BI 754091) • BI 836880
    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
    almost3years
    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, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Jan 2024 --> Jan 2025
    Trial completion date • Combination therapy • PD(L)-1 companion diagnostic
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    ezabenlimab (BI 754091) • BI 836880
    almost3years
    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
    almost3years
    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, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Jun 2023 --> Jan 2024 | Trial primary completion date: Feb 2023 --> Feb 2022
    Trial completion date • Trial primary completion date • Combination therapy • PD(L)-1 companion diagnostic
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    ezabenlimab (BI 754091) • BI 836880
    almost3years
    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, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • PD(L)-1 companion diagnostic
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    ezabenlimab (BI 754091) • BI 836880
    3years
    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=305, Recruiting, Boehringer Ingelheim | Trial completion date: Dec 2021 --> Jul 2023 | Trial primary completion date: Aug 2021 --> Mar 2023
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • PD(L)-1 companion diagnostic
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    ezabenlimab (BI 754091) • BI 836880
    over3years
    [VIRTUAL] Preclinical evaluation of VEGF Ang2 bispecific nanobody BI836880 in patient-derived xenograft models of nasopharyngeal carcinoma (AACR 2021)
    Angiogenesis marker CD34 was analyzed by IHC staining and the microvessel densities were calculated by Image J. The results showed that BI836880 could significantly reduce the numbers of microvessels to a comparable extent as bevacizumab in NPC model. In addition, BI836880 had increased the tumor internal necrotic area by 118.7% compared to vehicle control in Xeno-2117 (p=0.0148), but the effect was insignificant in Xeno-666 (p=0.5467).In conclusion, BI836880 can inhibit NPC growth to an extent that is comparable to bevacizumab, further investigation in combination with cytotoxic or immunotherapeutic agents are warranted.
    Preclinical • IO biomarker
    |
    VEGFA (Vascular endothelial growth factor A) • CD34 (CD34 molecule)
    |
    Avastin (bevacizumab) • BI 836880
    4years
    A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, Boehringer Ingelheim | N=120 --> 0 | Trial completion date: Sep 2023 --> Oct 2020 | Recruiting --> Withdrawn | Trial primary completion date: Mar 2023 --> Oct 2020
    Clinical • Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    ezabenlimab (BI 754091) • BI 836880
    4years
    A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer (clinicaltrials.gov)
    P2, N=120, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    ezabenlimab (BI 754091) • BI 836880
    4years
    Nintedanib and a bi-specific anti-VEGF/Ang2 nanobody selectively prevent brain metastases of lung adenocarcinoma cells. (PubMed, Clin Exp Metastasis)
    This data indicates a brain-specific group effect of antiangiogenic compounds with respect to metastasis prevention, most likely by preventing an early angiogenic switch. Thus, Nintedanib and BI836880 are promising candidates for future BM preventive study concepts in lung adenocarcinoma patients.
    Journal
    |
    ANGPT2 (Angiopoietin 2)
    |
    nintedanib • BI 836880
    over4years
    A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Boehringer Ingelheim
    Clinical • New P2 trial • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    ezabenlimab (BI 754091) • BI 836880
    over4years
    [VIRTUAL] Phase Ib study of BI 836880, a VEGF/Ang2-blocking nanobody®, in combination with BI 754091, an anti-PD-1 antibody: Initial results in patients (pts) with solid tumours (ESMO 2020)
    In Part 2 (expansion phase), patients are recruited to one of 7 cohorts: mNSCLC after CPI monotherapy; mNSCLC after CT + CPI; mSCLC after CT ± CPI; immunotherapy-resistant m-melanoma; recurrent glioblastoma after 1st-line CT; HCC after prior sorafenib or lenvatinib; and previously untreated/unresectable HCC. Funding: Boehringer Ingelheim. Clinical trial identification: NCT03468426.
    Clinical • P1 data • Combination therapy
    |
    VEGFA (Vascular endothelial growth factor A) • ANGPT2 (Angiopoietin 2)
    |
    sorafenib • Lenvima (lenvatinib) • ezabenlimab (BI 754091) • BI 836880
    over4years
    [VIRTUAL] Phase Ib study of BI 836880, a VEGF/Ang2-blocking nanobody, in combination with BI 754091, an anti-PD-1 antibody: Initial results in patients (pts) with advanced non-small cell lung cancer (NSCLC). (ASCO 2020)
    Part 2 will assess safety and efficacy in 6 expansion cohorts: mNSCLC after CPI monotherapy; mNSCLC after CT + CPI; mSCLC after CT ± CPI; immunotherapy-resistant m-melanoma; recurrent glioblastoma after 1st-line CT; and hepatocellular carcinoma after prior sorafenib or lenvatinib ± subsequent CPI. MTD/RP2D was BI 836880 720 mg plus BI 754091 240 mg q3w. The combination had a manageable safety profile, and preliminary anti-tumor activity was observed. Expansion cohorts are ongoing.
    Clinical • P1 data • Combination therapy
    |
    VEGFA (Vascular endothelial growth factor A) • ANGPT2 (Angiopoietin 2)
    |
    sorafenib • Lenvima (lenvatinib) • ezabenlimab (BI 754091) • BI 836880
    over4years
    A Study to Test Different Doses of BI 836880 Combined With BI 754091 in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (clinicaltrials.gov)
    P1, N=245, Recruiting, Boehringer Ingelheim | Trial completion date: Aug 2021 --> Dec 2021
    Clinical • Trial completion date • Combination therapy • PD(L)-1 companion diagnostic
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    ezabenlimab (BI 754091) • BI 836880