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    1m
    ABSK021-108: A Study to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules in Healthy Subjects (clinicaltrials.gov)
    P1, N=26, Not yet recruiting, Abbisko Therapeutics Co, Ltd
    New P1 trial
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    pimicotinib (ABSK021)
    2ms
    ABSK021-106: The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects with Mild and Moderate Hepatic Impairment Relative to Subjects with Normal Hepatic Function (clinicaltrials.gov)
    P1, N=24, Enrolling by invitation, Abbisko Therapeutics Co, Ltd | Not yet recruiting --> Enrolling by invitation
    Enrollment open
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    pimicotinib (ABSK021)
    4ms
    The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Abbisko Therapeutics Co, Ltd
    New P1 trial
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    pimicotinib (ABSK021)
    4ms
    A Clinical Trial to Evaluate the Effect of Itraconazole and Rifampicin on ABSK021 (clinicaltrials.gov)
    P1, N=32, Completed, Abbisko Therapeutics Co, Ltd | Enrolling by invitation --> Completed | Trial completion date: Nov 2023 --> Sep 2023
    Trial completion • Trial completion date
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    itraconazole • pimicotinib (ABSK021) • rifampicin
    4ms
    A Mass Balance Study of [14C]ABSK021 (clinicaltrials.gov)
    P1, N=6, Completed, Abbisko Therapeutics Co, Ltd | Recruiting --> Completed | N=10 --> 6
    Trial completion • Enrollment change
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    pimicotinib (ABSK021)
    4ms
    ABSK021 Food Effect Study in Healthy Subjects (clinicaltrials.gov)
    P1, N=16, Completed, Abbisko Therapeutics Co, Ltd | Not yet recruiting --> Completed
    Trial completion
    |
    pimicotinib (ABSK021)
    4ms
    A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD) (clinicaltrials.gov)
    P2, N=64, Enrolling by invitation, Abbisko Therapeutics Co, Ltd | Recruiting --> Enrolling by invitation
    Enrollment status
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    pimicotinib (ABSK021)
    5ms
    A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor (clinicaltrials.gov)
    P1, N=85, Recruiting, Abbisko Therapeutics Co, Ltd | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    pimicotinib (ABSK021)
    9ms
    Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER) (clinicaltrials.gov)
    P3, N=90, Active, not recruiting, Abbisko Therapeutics Co, Ltd | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    pimicotinib (ABSK021)
    9ms
    A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021 (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, Abbisko Therapeutics Co, Ltd
    New P1 trial
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    pimicotinib (ABSK021) • omeprazole
    12ms
    A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD) (clinicaltrials.gov)
    P2, N=64, Recruiting, Abbisko Therapeutics Co, Ltd
    New P2 trial
    |
    pimicotinib (ABSK021)
    12ms
    A Mass Balance Study of [14C]ABSK021 (clinicaltrials.gov)
    P1, N=10, Recruiting, Abbisko Therapeutics Co, Ltd
    New P1 trial
    |
    pimicotinib (ABSK021)
    12ms
    Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER) (clinicaltrials.gov)
    P3, N=90, Recruiting, Abbisko Therapeutics Co, Ltd
    Trial completion date • Trial primary completion date
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    pimicotinib (ABSK021)
    1year
    A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P2, N=82, Recruiting, Abbisko Therapeutics Co, Ltd
    New P2 trial • Combination therapy • Metastases
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    gemcitabine • Loqtorzi (toripalimab-tpzi) • Conmana (icotinib) • pimicotinib (ABSK021)
    over1year
    UPDATED EFFICACY AND SAFETY PROFILE OF PIMICOTINIB (ABSK021) IN TENOSYNOVIAL GIANT CELL TUMOR (TGCT): 1-YEAR FOLLOW-UP FROM PHASE 1B (CTOS 2023)
    With the extension of treatment duration, there is an observed augmentation in the number of pts experiencing sustained tumor shrinkage and favorable safety of Pimicotinib with no apparent hepatotoxicity. Current data confers durable therapeutic benefits in TGCT pts, suggesting that prolonged exposure may represent an optimal treatment approach. In addition, a separate cohort with prior anti-CSF-1/CSF-1R therapies is underway to assess the safety and antitumor activity.
    Clinical • P1 data
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    CSF1R (Colony stimulating factor 1 receptor)
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    CSF1R overexpression
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    Conmana (icotinib) • pimicotinib (ABSK021)
    over1year
    Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (clinicaltrials.gov)
    P3, N=90, Recruiting, Abbisko Therapeutics Co, Ltd | Not yet recruiting --> Recruiting
    Enrollment open
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    Conmana (icotinib) • pimicotinib (ABSK021)
    almost2years
    A potent and selective small molecule inhibitor of CSF-1R ABSK021 demonstrates strong efficacy in preclinical models of osteosarcoma (AACR 2023)
    Taken together, these results demonstrate that ABSK021 has strong inhibition of CSF-1R activity and corresponding anti-tumor activity in preclinical osteosarcoma models. High prevalence of CSF-1R expression was also found in osteosarcoma patients, suggesting great potential of utilizing ABSK021 as a novel therapy to treat osteosarcoma patients in clinic.
    Preclinical • Late-breaking abstract
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    CSF1R (Colony stimulating factor 1 receptor)
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    pimicotinib (ABSK021)
    almost2years
    A next-generation KRASG12C inhibitor ABSK071 demonstrated broad synergy with other therapeutic agents in KRASG12C mutated cancer models (AACR 2023)
    A set of immuno-oncology reagents, including anti-PD-1/L1, CSF-1R inhibitor (ABSK021) and CD73 inhibitor (ABSK051) were also tested in combination with ABSK071 in vivo using mouse syngeneic models. ABSK071 demonstrated much stronger inhibitory activity than sotorasib and adagrasib against a variety of cell lines harboring KRASG12C, as well as significantly better in vivo anti-tumor efficacy in xenograft models that were less sensitive to sotorasib. Synergistic effects on cell growth inhibition were observed in vitro with ABSK071 in combination with several agents including cetuximab, afatinib, AZD4547, TNO-155, RMC-4630 and BI3406... ABSK071 is a next-generation KRASG12C inhibitor with greater activity and anti-tumor efficacy in vitro and in vivo. It also demonstrated broad synergistic effects with a large set of targeted agents and immuno-oncology agents, indicating its strong potential in combinatory therapy in treating a wider range of KRASG12C-dependent cancers.
    Preclinical • Late-breaking abstract • PD(L)-1 Biomarker • IO biomarker
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    KRAS (KRAS proto-oncogene GTPase)
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    KRAS mutation
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    Erbitux (cetuximab) • Gilotrif (afatinib) • Lumakras (sotorasib) • Krazati (adagrasib) • fexagratinib (ABSK091) • BI-3406 • batoprotafib (TNO155) • vociprotafib (RMC-4630) • ABSK071 • pimicotinib (ABSK021) • ABSK051