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    DRUG:

    vabametkib (ABN401)

    i
    Other names: ABN401, ABN 401, ABN-401
    Company:
    Abion
    Drug class:
    c-MET inhibitor
    Related drugs:
    5d
    Synergistic Antitumor Activity of Combination Therapy with a MET TKI Vabametkib and a Third-Generation EGFR TKI Lazertinib in MET-Amplified EGFR-Mutant NSCLC. (PubMed, Cancer Res Treat)
    Inhibition of downstream signaling and cell proliferation by vabametkib plus lazertinib were evaluated in osimertinib-resistance NSCLC cell lines (HCC827-AR) and patient-derived organoid (YUO-010) by western blot and Cell Titer-Glo assay. Consistent with the in vitro findings, treatment with vabametkib plus lazertinib produced pronounced suppression of tumor growth in both models through a synergistic mechanism. These findings establish vabametkib plus lazertinib as a promising strategy for MET-amplified NSCLC, currently under evaluation in an ongoing phase II clinical trial (NCT05541822).
    Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • MET amplification • MET mutation
    |
    Tagrisso (osimertinib) • Lazcluze (lazertinib) • vabametkib (ABN401)
    11ms
    To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation (clinicaltrials.gov)
    P2, N=178, Recruiting, Abion Inc | N=40 --> 178 | Trial completion date: Aug 2025 --> Feb 2029 | Trial primary completion date: Apr 2025 --> Feb 2029
    Enrollment change • Trial completion date • Trial primary completion date
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    Lazcluze (lazertinib) • vabametkib (ABN401)
    over1year
    To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer Harboring c-MET Dysregulation (clinicaltrials.gov)
    P1, N=24, Completed, Abion Inc | Recruiting --> Completed | N=78 --> 24
    Trial completion • Enrollment change
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET overexpression
    |
    vabametkib (ABN401)
    over1year
    c-MET Inhibitor in Advanced Solid Tumors With c-MET Gene Aberration (clinicaltrials.gov)
    P2, N=20, Recruiting, Yonsei University | Not yet recruiting --> Recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment open • Trial completion date • Trial primary completion date • Pan tumor • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation
    |
    vabametkib (ABN401)
    2years
    To Evaluate the Safety, Pharmacokinetic and the Effect of Food After Administration of ABN401 in Healthy Adult Volunteers (clinicaltrials.gov)
    P1, N=25, Completed, Abion Inc | Recruiting --> Completed
    Trial completion
    |
    vabametkib (ABN401)
    2years
    To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer Harboring c-MET Dysregulation (clinicaltrials.gov)
    P1, N=78, Recruiting, Abion Inc | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET overexpression
    |
    vabametkib (ABN401)
    over2years
    To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer Harboring c-MET Dysregulation (clinicaltrials.gov)
    P1, N=78, Recruiting, Abion Inc | Phase classification: P1/2 --> P1
    Phase classification • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET overexpression
    |
    vabametkib (ABN401)
    almost3years
    A Phase II Study of ABN401 in Advanced Solid Tumors With c-MET Gene Aberration (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Yonsei University
    New P2 trial • Pan tumor • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation
    |
    vabametkib (ABN401)
    almost3years
    ABN401 in patients with NSCLC with MET exon 14 (METex14) skipping: Result from the pilot expansion study. (ASCO 2023)
    The ABN401 pilot expansion part of phase 1 demonstrated promising anti-tumor effects and safety in NSCLC pts with c-MET dysregulation, providing support for further evaluation of ABN401 in the METex14 skipping cohort (cohort-1) of the global phase 2 study (NCT05541822). Enrollment is currently ongoing. References National Comprehensive Cancer Network: Non-small cell lung cancer (version 2.2021).
    Clinical
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET overexpression
    |
    vabametkib (ABN401)
    3years
    Synergistic anti-tumor effect of ABN401 in combination with KRAS inhibitor in a c-MET-altered KRASG12C non-small cell lung cancer model (AACR 2023)
    We have performed several in vitro and in vivo efficacy studies for the combination of ABN401, c-MET inhibitor, and sotorasib, KRASG12C variant inhibitor, including a PDX model of c-MET-altered KRASG12C NSCLC. Our results suggest that the combination of ABN401 and KRAS inhibitor could be an alternative treatment option for c-MET-altered KRASG12C NSCLC patients.
    Preclinical • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • MET expression
    |
    Lumakras (sotorasib) • vabametkib (ABN401)
    3years
    To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation (clinicaltrials.gov)
    P2, N=40, Recruiting, Abion Inc | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    vabametkib (ABN401)