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    DRUG:

    zongertinib (BI 1810631)

    i
    Other names: BI 1810631, BI1810631, BI-1810631
    Company:
    Boehringer Ingelheim
    Drug class:
    HER2 exon 20 mutation inhibitor
    Related drugs:
    18d
    A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body (clinicaltrials.gov)
    P1, N=16, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    zongertinib (BI 1810631) • midazolam hydrochloride • omeprazole
    1m
    BEAMION-Lung 1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) (clinicaltrials.gov)
    P1, N=554, Recruiting, Boehringer Ingelheim | Trial primary completion date: Dec 2025 --> Mar 2026
    Trial primary completion date • Metastases
    |
    NRG1 (Neuregulin 1)
    |
    EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    zongertinib (BI 1810631)
    1m
    A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood (clinicaltrials.gov)
    P1, N=32, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    zongertinib (BI 1810631) • metformin
    2ms
    Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations (clinicaltrials.gov)
    P2, N=200, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open • Pan tumor • Metastases
    |
    zongertinib (BI 1810631)
    2ms
    Zongertinib (BI 1810631), an irreversible HER2 TKI, spares EGFR signaling and improves therapeutic response in preclinical models and patients with HER2-driven cancers. (PubMed, Cancer Discov)
    Zongertinib potently and selectively blocks HER2, while sparing EGFR, and inhibits the growth of cells dependent on HER2 oncogenic driver events, including HER2-dependent human cancer cells resistant to trastuzumab deruxtecan. Zongertinib displays potent anti-tumor activity in HER2-dependent human NSCLC xenograft models and enhances the activities of antibody-drug conjugates and KRASG12C inhibitors, without causing obvious toxicities. The preclinical efficacy of zongertinib translates in objective responses in patients with HER2-dependent tumors, including cholangiocarcinoma (SDC4-NRG1 fusion) and breast cancer (V777L HER2 mutation) thus supporting the ongoing clinical development of zongertinib.
    Preclinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • NRG1 (Neuregulin 1) • SDC4 (Syndecan 4)
    |
    HER-2 mutation • NRG1 fusion • HER-2 V777L • NRG1 fusion • SDC4-NRG1 fusion
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • zongertinib (BI 1810631)
    2ms
    Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations (clinicaltrials.gov)
    P2, N=200, Not yet recruiting, Boehringer Ingelheim
    New P2 trial • Pan tumor • Metastases
    |
    zongertinib (BI 1810631)
    3ms
    A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    zongertinib (BI 1810631) • midazolam hydrochloride • omeprazole
    3ms
    A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood (clinicaltrials.gov)
    P1, N=32, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open
    |
    zongertinib (BI 1810631) • metformin
    4ms
    A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body (clinicaltrials.gov)
    P1, N=16, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open
    |
    zongertinib (BI 1810631) • midazolam hydrochloride • omeprazole
    4ms
    A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood (clinicaltrials.gov)
    P1, N=32, Not yet recruiting, Boehringer Ingelheim
    New P1 trial
    |
    zongertinib (BI 1810631) • metformin
    4ms
    A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body (clinicaltrials.gov)
    P1, N=16, Not yet recruiting, Boehringer Ingelheim
    New P1 trial
    |
    zongertinib (BI 1810631) • midazolam hydrochloride • omeprazole
    4ms
    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, Completed, Boehringer Ingelheim | Active, not recruiting --> Completed
    Trial completion
    |
    zongertinib (BI 1810631)
    4ms
    BEAMION-Lung 1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) (clinicaltrials.gov)
    P1, N=554, Recruiting, Boehringer Ingelheim | N=371 --> 554
    Enrollment change • Metastases
    |
    NRG1 (Neuregulin 1)
    |
    zongertinib (BI 1810631)
    5ms
    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, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    zongertinib (BI 1810631)
    6ms
    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, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • zongertinib (BI 1810631)
    6ms
    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, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open
    |
    zongertinib (BI 1810631)
    7ms
    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)
    8ms
    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)
    10ms
    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)
    11ms
    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)
    11ms
    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)
    12ms
    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)
    12ms
    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)
    12ms
    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)
    1year
    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)
    1year
    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)
    1year
    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)
    1year
    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)
    over1year
    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)
    over1year
    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)
    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=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)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    almost2years
    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)
    2years
    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)
    2years
    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)
    2years
    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)
    over2years
    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)
    over2years
    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)