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    DRUG:

    GS-0189

    i
    Other names: FSI-189, FSI 189, GS-0189, FSI189
    Associations

    News

    Trials
    Company:
    Gilead
    Drug class:
    SIRPA inhibitor
    Related drugs:
    Associations

    News

    Trials
    over1year
    A phase 1 first-in-human study of GS-0189, an anti-signal regulatory protein alpha (SIRPα) monoclonal antibody, in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). (PubMed, EJHaem)
    Here we report: (1) clinical safety, preliminary activity, and pharmacokinetics of GS-0189 as monotherapy and in combination with rituximab from a phase 1 clinical trial in patients with relapsed/refractory NHL (NCT04502706, SRP001); (2) in vitro characterization of GS-0189 binding to SIRPα; and (3) in vitro phagocytic activity. In vitro phagocytosis induced by GS-0189 was also SIRPα variant-dependent. Although clinical development of GS-0189 was discontinued, the CD47-SIRPα signaling pathway remains a promising therapeutic target and should continue to be explored.
    P1 data • Journal
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Rituxan (rituximab) • GS-0189
    over2years
    Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=9, Terminated, Gilead Sciences | Trial completion date: Mar 2024 --> Mar 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2023 --> Mar 2022; Sponsor's decision to discontinue development of this molecule
    Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Rituxan (rituximab) • GS-0189
    over2years
    Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting | N=81 --> 9 | Trial primary completion date: Sep 2022 --> Sep 2023
    Enrollment closed • Enrollment change • Trial primary completion date • Combination therapy
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Rituxan (rituximab) • GS-0189
    3years
    Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=81, Recruiting, Gilead Sciences | Trial completion date: Aug 2023 --> Mar 2024 | Trial primary completion date: Mar 2022 --> Sep 2022
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Rituxan (rituximab) • GS-0189
    over3years
    Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=75, Recruiting, Gilead Sciences | Trial primary completion date: Dec 2021 --> Mar 2022
    Clinical • Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • SIRPA (Signal Regulatory Protein Alpha)
    |
    CD20 expression
    |
    Rituxan (rituximab) • GS-0189
    4years
    Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=63, Recruiting, Gilead Sciences | Not yet recruiting --> Recruiting | Trial completion date: Sep 2022 --> Aug 2023
    Clinical • Enrollment open • Trial completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • SIRPA (Signal Regulatory Protein Alpha)
    |
    CD20 expression
    |
    Rituxan (rituximab) • GS-0189
    over4years
    Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=63, Not yet recruiting, Gilead Sciences
    Clinical • New P1 trial • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • SIRPA (Signal Regulatory Protein Alpha)
    |
    CD20 expression
    |
    Rituxan (rituximab) • GS-0189