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    DRUG:

    ABBV-CLS-579

    i
    Other names: ABBV-CLS-579, ABBV 579
    Associations

    News

    Trials
    Company:
    AbbVie, Calico Life Sciences
    Drug class:
    PTP-1B inhibitor, PTPN2 inhibitor
    Related drugs:
    Associations

    News

    Trials
    2ms
    First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors (clinicaltrials.gov)
    P1, N=101, Completed, AbbVie | Active, not recruiting --> Completed
    Trial completion • First-in-human
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    PD-L1 IHC 22C3 pharmDx
    |
    ABBV-CLS-579
    4ms
    First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors (clinicaltrials.gov)
    P1, N=101, Active, not recruiting, AbbVie | Trial completion date: May 2026 --> Aug 2025 | Trial primary completion date: May 2026 --> Aug 2025
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    PD-L1 IHC 22C3 pharmDx
    |
    ABBV-CLS-579
    1year
    First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors (clinicaltrials.gov)
    P1; Recruiting --> Active, not recruiting | N=263 --> 101 | Trial primary completion date: Aug 2025 --> May 2026
    Trial primary completion date • Enrollment change • Enrollment closed
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    PD-L1 IHC 22C3 pharmDx
    |
    ABBV-CLS-579
    2years
    First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors (clinicaltrials.gov)
    P1; Trial completion date: Sep 2023 --> Apr 2026 | Trial primary completion date: Sep 2023 --> Aug 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    PD-L1 IHC 22C3 pharmDx
    |
    ABBV-CLS-579
    over2years
    First-in-human phase 1 studies of PTPN2/1 inhibitors ABBV-CLS-484 and ABBV-CLS-579 in locally advanced or metastatic tumors (AACR 2023)
    Preclinical data also indicated that PTPN2/1 inhibitors have improved efficacy when combined with PD-1-targeting agents (eg, pembrolizumab) or vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) in multiple tumor models. Evaluation of objective response rate (RECIST v1.1) is a primary objective in EXP phase and a secondary objective in ESC phase. Both studies are active, and as of 30 Nov 2022, 30 (ABBV-CLS-484) and 45 (ABBV-CLS-579) patients had been enrolled in ESC phase.
    P1 data • Metastases
    |
    MSI (Microsatellite instability) • IFNG (Interferon, gamma) • PTPN2 (Protein Tyrosine Phosphatase Non-Receptor Type 2)
    |
    MSI-H/dMMR • PTPN2 mutation
    |
    Keytruda (pembrolizumab) • ABBV-CLS-579 • osunprotafib (ABBV-CLS-484)
    over3years
    First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors (clinicaltrials.gov)
    P1; N=43 --> 263
    Enrollment change
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR
    |
    PD-L1 IHC 22C3 pharmDx
    |
    ABBV-CLS-579