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    DRUG:

    zongertinib (BI 1810631)

    i
    Other names: BI 1810631
    Company:
    Boehringer Ingelheim
    Drug class:
    HER2 exon 20 mutation inhibitor
    Related drugs:
    27d
    A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers (clinicaltrials.gov)
    P1, N=56, Not yet recruiting, Boehringer Ingelheim
    New P1 trial
    |
    zongertinib (BI 1810631)
    2ms
    Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread (clinicaltrials.gov)
    P1/2, N=240, Not yet recruiting, Boehringer Ingelheim
    New P1/2 trial • Combination therapy • Metastases
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • zongertinib (BI 1810631)
    3ms
    Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment (clinicaltrials.gov)
    P3, N=270, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • zongertinib (BI 1810631)
    4ms
    A Study in Healthy Men to Test How BI 1810631 is Taken up in the Body When Taken With or Without Food (clinicaltrials.gov)
    P1, N=16, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    zongertinib (BI 1810631)
    5ms
    A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of BI 1810631 in the Blood (clinicaltrials.gov)
    P1, N=16, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    zongertinib (BI 1810631)
    5ms
    Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment (clinicaltrials.gov)
    P3, N=270, Not yet recruiting, Boehringer Ingelheim
    New P3 trial
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • zongertinib (BI 1810631)
    5ms
    Beamion LUNG-1: Phase Ia/b Trial of HER2 Tyrosine Kinase Inhibitor Zongertinib (BI 1810631) in Patients with HER2 Aberration-Positive Solid Tumors (IASLC-NACLC 2023)
    No abstract available
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    zongertinib (BI 1810631)
    5ms
    A Study in Healthy Men to Test How BI 1810631 is Taken up in the Body When Taken With or Without Food (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    zongertinib (BI 1810631)
    6ms
    A Study in Healthy Men to Test How BI 1810631 is Taken up in the Body When Taken With or Without Food (clinicaltrials.gov)
    P1, N=16, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open
    |
    zongertinib (BI 1810631)
    6ms
    BEAMION-Lung 1: A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) (clinicaltrials.gov)
    P1, N=371, Recruiting, Boehringer Ingelheim | Trial completion date: Dec 2025 --> Dec 2027
    Trial completion date • Metastases
    |
    NRG1 (Neuregulin 1)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    zongertinib (BI 1810631)
    7ms
    A Study in Healthy Men to Test How BI 1810631 is Taken up and Processed by the Body (clinicaltrials.gov)
    P1, N=15, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    zongertinib (BI 1810631)
    7ms
    A Study in Healthy Men to Test How BI 1810631 is Taken up in the Body When Taken With or Without Food (clinicaltrials.gov)
    P1, N=16, Not yet recruiting, Boehringer Ingelheim
    New P1 trial
    |
    zongertinib (BI 1810631)
    10ms
    Beamion Lung 1, an ongoing phase Ia/Ib trial of the HER2 TKI, BI 1810631 in patients (pts) with advanced solid tumors with HER2 aberrations: Latest data (ESMO 2023)
    Recruitment into phase Ib is ongoing with the QD regimen. Updated phase 1a data, and emerging Phase1b data, will be presented.
    Clinical • P1 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    |
    zongertinib (BI 1810631)
    10ms
    Beamion Lung 1, a Phase Ia/Ib Trial of the HER2 TKI, BI 1810631 in Patients with Advanced Solid Tumors with HER2 Aberrations (IASLC-WCLC 2023)
    These preliminary data indicate that BI 1810631 is well tolerated and shows strong efficacy signals across all dose levels in patients with pre-treated HER2 aberration-positive solid tumors. Recruitment into Phase Ib is ongoing with the QD regimen. Updated Phase Ia data, and emerging Phase Ib data, will be presented.
    Clinical • P1 data • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 exon 20 mutation
    |
    zongertinib (BI 1810631)
    11ms
    A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) (clinicaltrials.gov)
    P1, N=371, Recruiting, Boehringer Ingelheim | N=266 --> 371
    Enrollment change • Metastases
    |
    NRG1 (Neuregulin 1)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    zongertinib (BI 1810631)
    1year
    Phase I Beamion Lung 1 trial of BI 1810631, a HER2 tyrosine kinase inhibitor (TKI), as monotherapy in patients (pts) with advanced/metastatic solid tumors with HER2 aberrations: Updated data. (ASCO 2023)
    These preliminary data indicate that BI 1810631 is well tolerated and shows encouraging anti-tumor activity in pts with HER2 aberration-positive solid tumors. Recruitment into Phase Ia is ongoing. Updated data, including durability endpoints, will be presented.
    Clinical • P1 data • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 exon 20 mutation
    |
    zongertinib (BI 1810631)
    1year
    Updated data from the Phase I Beamion Lung 1 trial of the HER2 tyrosine kinase inhibitor (TKI), BI 1810631, as monotherapy in patients (pts) with advanced/metastatic solid tumors with HER2 aberrations (AACR 2023)
    These preliminary data indicate that BI 1810631 is well tolerated and shows encouraging anti-tumor activity in pts with HER2 aberration-positive solid tumors. Recruitment into Phase Ia is ongoing.
    Clinical • P1 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 exon 20 mutation
    |
    zongertinib (BI 1810631)
    1year
    A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations. (PubMed, Clin Lung Cancer)
    BI 1810631 could be an effective and tolerable EGFR-sparing oral treatment for patients with HER2 mutation-positive NSCLC, including exon 20 insertion mutations.
    Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 mutation • HER-2 exon 20 mutation
    |
    zongertinib (BI 1810631)
    1year
    Updated data from the Phase I Beamion Lung 1 trial of BI 1810631, a HER2 TKI, in patients (pts) with advanced solid tumours with HER2 aberrations (ELCC 2023)
    Conclusions Preliminary data indicate that BI 1810631 is well tolerated and shows encouraging anti-tumour activity in pts with HER2 aberration-positive solid tumours. Phase Ia recruitment is ongoing.
    Clinical • P1 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    zongertinib (BI 1810631)
    over1year
    A Phase 1 Trial of BI 1810631, a HER2 Tyrosine Kinase Inhibitor (TKI), as Monotherapy in Patients with Advanced/Metastatic Solid Tumors with HER2 Aberrations (IASLC-TTLC 2023)
    (BIPI). BIPI was given the opportunity to review the abstract for medical and scientific accuracy as well as intellectual property considerations.
    Clinical • P1 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 exon 20 mutation
    |
    zongertinib (BI 1810631)
    over1year
    A Phase I trial of BI 1810631, a HER2 tyrosine kinase inhibitor (TKI), as monotherapy in patients (pts) with advanced/metastatic solid tumors with HER2 aberrations (AACR-NCI-EORTC 2022)
    These preliminary data indicate that BI 1810631 is well tolerated and shows encouraging anti-tumor activity in patients with HER2 aberration-positive solid tumors. Recruitment into Phase Ia is ongoing.
    Clinical • P1 data • Late-breaking abstract
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 exon 20 mutation
    |
    zongertinib (BI 1810631)
    over1year
    A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) (clinicaltrials.gov)
    P1, N=266, Recruiting, Boehringer Ingelheim | Trial primary completion date: Feb 2024 --> Dec 2025
    Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • NRG1 (Neuregulin 1)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    zongertinib (BI 1810631)
    over1year
    A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) (clinicaltrials.gov)
    P1, N=266, Recruiting, Boehringer Ingelheim | Trial completion date: Oct 2024 --> Dec 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • NRG1 (Neuregulin 1)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    zongertinib (BI 1810631)
    over1year
    A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) (clinicaltrials.gov)
    P1, N=266, Recruiting, Boehringer Ingelheim | N=96 --> 266
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • NRG1 (Neuregulin 1)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    zongertinib (BI 1810631)
    almost2years
    A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) (clinicaltrials.gov)
    P1, N=96, Recruiting, Boehringer Ingelheim | Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Sep 2023 --> Feb 2024
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • NRG1 (Neuregulin 1)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    zongertinib (BI 1810631)
    almost2years
    A Phase I Trial of the HER2 Exon 20 Inhibitor, BI 1810631, In Patients With Advanced Solid Tumors With HER2 Aberrations (IASLC-WCLC 2022)
    Despite the promise of trastuzumab deruxtecan and other agents in this setting, the development of orally available selective TKIs is important given the heterogeneity of HER2 aberrations, potential for combination regimens, and the risk of interstitial lung disease with ADCs. Two dose levels have been completed to date with no DLTs. Recruitment to Phase Ia will continue until the MTD/RP2D is determined.
    Clinical • P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • NRG1 (Neuregulin 1)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation • EGFR wild-type • HER-2 exon 20 mutation • HER-2 exon 23 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • zongertinib (BI 1810631)
    2years
    A phase I, open-label, dose escalation, confirmation, and expansion trial of BI 1810631 as monotherapy in patients with advanced/metastatic solid tumors with HER2 aberrations. (ASCO 2022)
    Despite the promise of trastuzumab deruxtecan and other agents in this setting, the development of orally available selective TKIs is important given the heterogeneity of HER2 aberrations, potential for combination regimens, and the risk of ILD with ADCs. The trial is actively recruiting with 6 pts enrolled to date. More patients may be recruited depending on whether 2 dose levels have been completed and the MTD/RP2D determined.
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • NRG1 (Neuregulin 1)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation • EGFR wild-type
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • zongertinib (BI 1810631)
    2years
    A phase I, open-label, dose escalation, confirmation, and expansion trial of BI 1810631 as monotherapy in patients with advanced or metastatic solid tumors with HER2 aberrations (AACR 2022)
    Despite the promise of trastuzumab deruxtecan and other agents in this setting, the development of orally available selective TKIs is important given the heterogeneity of HER2 aberrations, potential for combinations regimens, and the risk of ILD with ADCs. Secondary endpoints: number of pts with DLTs throughout entire treatment period and PK parameters (Phase Ia/Ib); duration of response, PFS, disease control, and duration of disease control (Phase Ib). The trial is actively recruiting; 5 pts have been enrolled to date and 2 dose levels have been completed.
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • NRG1 (Neuregulin 1)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • zongertinib (BI 1810631)
    2years
    A phase I, open-label, dose escalation, confirmation, and expansion trial of BI 1810631 as monotherapy in patients with advanced or metastatic solid tumors with HER2 aberrations (ELCC 2022)
    Secondary endpoints: number of pts with DLTs throughout entire treatment period and PK parameters (Phase Ia/Ib); duration of response, PFS, disease control, and duration of disease control (Phase Ib). The trial is actively recruiting; 5 pts have been enrolled to date and 2 dose levels have been completed.
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    |
    zongertinib (BI 1810631)
    almost3years
    A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) (clinicaltrials.gov)
    P1, N=96, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • NRG1 (Neuregulin 1)
    |
    BRAF V600E • EGFR mutation • HER-2 overexpression • HER-2 amplification • BRAF V600 • HER-2 mutation • EGFR T790M • ALK rearrangement • HER-2 exon 20 insertion • HER-2 exon 20 mutation
    |
    zongertinib (BI 1810631)
    almost3years
    A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) (clinicaltrials.gov)
    P1, N=96, Not yet recruiting, Boehringer Ingelheim
    Clinical • New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • NRG1 (Neuregulin 1)
    |
    BRAF V600E • EGFR mutation • HER-2 overexpression • HER-2 amplification • BRAF V600 • HER-2 mutation • EGFR T790M • ALK rearrangement • HER-2 exon 20 insertion • HER-2 exon 20 mutation
    |
    zongertinib (BI 1810631)