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    DRUG:

    irpagratinib (ABSK011)

    i
    Other names: ABSK011, ABSK-011, ABSK 011
    Company:
    Abbisko
    Drug class:
    FGFR4 inhibitor
    Related drugs:
    7ms
    Improvements in advanced hepatocellular carcinoma to repeat implementation of primary protocol after cancer progression occurs following sequential systemic therapy and a clinical trial: A case report. (PubMed, Medicine (Baltimore))
    The combined treatment of TACE plus systemic therapy might be an appropriate subsequent treatment.
    Journal • Metastases
    |
    FGFR4 (Fibroblast growth factor receptor 4) • AFP (Alpha-fetoprotein)
    |
    Tyvyt (sintilimab) • Lenvima (lenvatinib) • irpagratinib (ABSK011)
    9ms
    A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules (clinicaltrials.gov)
    P1, N=73, Recruiting, Abbisko Therapeutics Co, Ltd
    New P1 trial
    |
    irpagratinib (ABSK011) • omeprazole
    over1year
    First-in-human study of ABSK-011, a novel, highly selective fibroblast growth factor receptor (FGFR) 4 inhibitor for treating advanced hepatocellular carcinoma (HCC) with FGF19 overexpression (ESMO 2023)
    Pathway inhibition was observed by increased C4, total bile acids, FGF19, and decreased total cholesterol at all dose levels. Conclusions The promising response rate and manageable safety profile from this phase I study suggest that ABSK-011 may have clinical benefit for HCC pts with prior therapies through biomarker selection of FGF19.
    P1 data • Metastases
    |
    FGF19 (Fibroblast growth factor 19) • FGFR4 (Fibroblast growth factor receptor 4)
    |
    FGF19 overexpression
    |
    irpagratinib (ABSK011)
    2years
    Inhibition of fibroblast growth factor receptor 4 (FGFR4) signaling activates tumor interferon (IFN) signaling in hepatocellular carcinoma (HCC) (SITC 2022)
    In addition, we found that ABSK011 increased CD8 + T cell infiltration in humanized HCC mouse models. Conclusions These preclinical data demonstrated that ABSK011 treatment increased IFN related response as well as CD8 + T cell infiltration in FGF19 overexpressed HCC models, supporting the combination of FGFR4 inhibitor and immune checkpoint molecules such as anti-PD-(L)1 antibodies to achieve enhanced antitumor activity.
    PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • FGF19 (Fibroblast growth factor 19) • FGFR4 (Fibroblast growth factor receptor 4) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • IRF1 (Interferon Regulatory Factor 1) • IFIT1 (Interferon Induced Protein With Tetratricopeptide Repeats 1)
    |
    PD-L1 expression • FGF19 overexpression • IRF1 expression
    |
    irpagratinib (ABSK011)
    2years
    A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab in HCC Patients (clinicaltrials.gov)
    P2, N=62, Recruiting, Abbisko Therapeutics Co, Ltd | Not yet recruiting --> Recruiting | Initiation date: Jul 2022 --> Dec 2021
    Enrollment open • Trial initiation date • Metastases
    |
    FGF19 (Fibroblast growth factor 19)
    |
    FGF19 overexpression
    |
    Tecentriq (atezolizumab) • irpagratinib (ABSK011)
    over2years
    A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=50, Recruiting, Abbisko Therapeutics Co, Ltd | Trial completion date: Jan 2023 --> Aug 2025 | Trial primary completion date: Oct 2022 --> Dec 2023
    Trial completion date • Trial primary completion date
    |
    FGF19 (Fibroblast growth factor 19)
    |
    FGF19 overexpression
    |
    irpagratinib (ABSK011)
    over3years
    A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=50, Recruiting, Abbisko Therapeutics Co, Ltd
    Clinical • New P1 trial
    |
    FGF19 (Fibroblast growth factor 19)
    |
    FGF19 overexpression
    |
    irpagratinib (ABSK011)