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    DRUG:

    STK-012

    i
    Other names: STK-012, engineered Interleukin-2 (IL-2)
    Associations

    News

    Trials
    Company:
    Synthekine
    Drug class:
    IL-2Rα partial agonist, IL-2Rβ partial agonist
    Associations

    News

    Trials
    1m
    STK-012-101: Study of STK-012 Alone and with Other Treatments in Patients with Advanced Lung Cancer and Other Cancers (2025-522632-14-00)
    P1/2, N=56, Not yet recruiting, Synthekine Inc.
    New P1/2 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 negative
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • STK-012
    4ms
    STK-012-101: Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers (clinicaltrials.gov)
    P1/2, N=364, Recruiting, Synthekine | Phase classification: P1 --> P1/2 | N=202 --> 364 | Trial completion date: Oct 2027 --> Jan 2029 | Trial primary completion date: Oct 2027 --> Jan 2029
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • STK-012
    over1year
    STK-012 Monotherapy and in Combination Therapy in Patients with Solid Tumors (clinicaltrials.gov)
    P1, N=202, Recruiting, Synthekine | Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Oct 2025 --> Oct 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • STK-012
    over2years
    Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=202, Recruiting, Synthekine | Phase classification: P1a/1b --> P1
    Phase classification
    |
    Keytruda (pembrolizumab) • STK-012
    4years
    A phase 1a/1b study of STK-012, an α/β IL-2 receptor selective partial agonist as monotherapy and in combination with pembrolizumab in advanced solid tumors (NCT05098132) (AACR 2022)
    In cynomolgus monkeys, acute lung inflammation was induced by aldesleukin and non-α-IL-2, but not by STK-012. Exploratory biomarker assessments will include peripheral and tumor measures of immune cell populations and relevant gene/protein expression. Enrollment in STK-012 monotherapy dose escalation has been initiated.
    P1 data • Combination therapy • MSi-H Biomarker • PD(L)-1 Biomarker
    |
    MSI (Microsatellite instability) • IL2RA (Interleukin 2 receptor, alpha) • IL2 (Interleukin 2)
    |
    MSI-H/dMMR
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    Keytruda (pembrolizumab) • Proleukin (aldesleukin) • STK-012
    5years
    [VIRTUAL] STK-012, an alpha/beta selective IL-2 mutein for the activation of the antigen-activated T cells in solid tumor (AACR 2021)
    STK-012 selectively induced memory T cell expansion, including CD28+ CD95+ CD8 T cells. In summary, STK-012 avoids IL-2 mediated toxicity and may enable the specific expansion of antigen activated memory T cells in cancer patients, leading to durable tumor response.
    PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD22 (CD22 Molecule) • IL2 (Interleukin 2) • FAS (Fas cell surface death receptor) • FCGR2A (Fc fragment of IgG receptor IIa) • FCGR2B (Fc Fragment Of IgG Receptor IIb)
    |
    STK-012 • docetaxel-HPG (STK-01)