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    DRUG:

    SAR445877

    i
    Other names: SAR445877, KD050, KD-050, mut-1N-IL-15/38B2, KD 050, SAR-445877, SAR 445877
    Associations

    News

    Trials
    Company:
    Sanofi
    Drug class:
    PD1 inhibitor, IL-15R stimulant, IL-2/15Rβγ agonist
    Related drugs:
    Associations

    News

    Trials
    20d
    A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=29, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    SAR445877
    1m
    A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=542, Recruiting, Sanofi | N=291 --> 542 | Trial completion date: Nov 2028 --> Jun 2028
    Enrollment change • Trial completion date • First-in-human
    |
    MSI (Microsatellite instability)
    |
    HER-2 negative
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • Erbitux (cetuximab) • Yervoy (ipilimumab) • SAR445877 • muzastotug (ADG126)
    4ms
    A Phase 2 Platform Study of Immunomodulatory Compounds in ICI-refractory Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=29, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    SAR445877
    over1year
    A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=285, Recruiting, Sanofi | Trial completion date: Mar 2028 --> Sep 2028
    Trial completion date • Combination therapy • Metastases
    |
    MSI (Microsatellite instability)
    |
    Erbitux (cetuximab) • SAR445877
    almost2years
    A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=240, Recruiting, Sanofi | Trial completion date: Jun 2027 --> Mar 2028 | Trial primary completion date: Apr 2027 --> Jan 2027
    Trial completion date • Trial primary completion date • Metastases
    |
    MSI (Microsatellite instability)
    |
    HER-2 negative
    |
    SAR445877
    over2years
    A phase I/II, open label, first-in-human, dose escalation and expansion study of SAR445877 administered as monotherapy in adults with advanced solid tumors (ESMO 2023)
    The study is enrolling participants. Lu D et al, J Immunother Cancer (2020); 8(Suppl 3):573.
    Clinical • P1/2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD8 (cluster of differentiation 8) • IL2 (Interleukin 2) • IL15 (Interleukin 15)
    |
    PD-L1 expression • CD8 expression
    |
    SAR445877
    over2years
    Preclinical characterization of SAR445877, an anti-PD-1 antibody-IL-15 mutein fusion protein with robust anti-tumor efficacy as monotherapy and in combination with PD-L1 blockade (AACR 2023)
    SAR445877 displayed a more potent antitumor efficacy than pembrolizumab. SAR445877 exhibited potent anti-tumor efficacy in PD-1 resistant preclinical model with good tolerability. These results support further evaluation of SAR445877 in a phase I clinical trial (ClinicalTrials.gov #NCT05584670).
    Preclinical • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • IL15 (Interleukin 15)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • SAR445877
    almost3years
    A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=240, Recruiting, Sanofi | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    MSI (Microsatellite instability)
    |
    HER-2 negative
    |
    SAR445877
    3years
    A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=240, Not yet recruiting, Sanofi
    New P1/2 trial • Metastases
    |
    MSI (Microsatellite instability)
    |
    HER-2 negative
    |
    SAR445877