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    9ms
    Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients (clinicaltrials.gov)
    P1/2, N=17, Terminated, SK Life Science, Inc. | N=96 --> 17 | Trial completion date: Sep 2024 --> Mar 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2024 --> Mar 2024; The study has been terminated based on portfolio prioritization. No safety trends or issues were identified at any dose level.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
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    PD-L1 (Programmed death ligand 1) • BRCA (Breast cancer early onset)
    |
    PD-L1 expression • BRAF V600E • BRAF V600 • BRCA mutation
    |
    SKL27969
    11ms
    Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients (clinicaltrials.gov)
    P1/2, N=96, Active, not recruiting, SK Life Science, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
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    PD-L1 (Programmed death ligand 1) • BRCA (Breast cancer early onset)
    |
    PD-L1 expression • BRAF V600E • BRAF V600 • BRCA mutation
    |
    SKL27969
    1year
    Tumor pharmacokinetics and pharmacodynamics in patient-derived xenograft models of glioblastoma treated with the PRMT5 inhibitor SKL27969 (SNO 2023)
    SKL27969 is well tolerated, achieves pharmacologically relevant unbound concentrations in GBM PDX models, and is associated with significant target modulation. Ongoing studies are evaluating in vivo survival benefit from combining PRMT5 inhibition with radiation therapy.
    PK/PD data • Preclinical
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    CASP3 (Caspase 3)
    |
    SKL27969
    1year
    Tumor pharmacokinetics and pharmacodynamics in patient-derived xenograft models of glioblastoma treated with the PRMT5 inhibitor SKL27969 (SNO 2023)
    SKL27969 is well tolerated, achieves pharmacologically relevant unbound concentrations in GBM PDX models, and is associated with significant target modulation. Ongoing studies are evaluating in vivo survival benefit from combining PRMT5 inhibition with radiation therapy.
    PK/PD data • Preclinical
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    CASP3 (Caspase 3)
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    SKL27969
    almost2years
    SKL27969, an oral selective PRMT5 inhibitor, sensitizes the effect of DNA-damaging agents in preclinical models of multiple solid tumors (AACR 2023)
    Robust antitumor effects were observed after treatment with SKL27969 in combination with paclitaxel or gemcitabine in NSCLC PDX or pancreatic cancer CDX models. This is the first preclinical study that suggests the therapeutic potential of SKL27969 in combination with currently approved DNA-damaging agents, and supports further clinical investigation of SKL27969’s role in improving the therapeutic benefit of standard therapies.
    Preclinical
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    PRMT5 (Protein Arginine Methyltransferase 5)
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    gemcitabine • paclitaxel • SKL27969
    2years
    Discovery and pharmacological characterization of SKL27969, a novel brain-penetrating PRMT5 inhibitor with strong antitumor activity, in glioblastoma and brain metastasis preclinical models (SNO 2022)
    Furthermore, SKL27969 showed potentiation of DNA damage when used in combination with DNA-damaging agents, which may suggest possible benefit as a combination therapy. Given the therapeutic target potential of PRMT5 in glioblastoma and other brain metastatic cancers, and the preclinical efficacy of SKL27969, these results have enabled the initiation of Phase 1/2 open-label, multicenter dose-finding study in patients with advanced solid tumors (NCT05388435).
    Preclinical
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    PRMT5 (Protein Arginine Methyltransferase 5)
    |
    SKL27969
    over2years
    Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients (clinicaltrials.gov)
    P1/2, N=96, Recruiting, SK Life Science, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
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    PD-L1 (Programmed death ligand 1) • BRCA (Breast cancer early onset)
    |
    PD-L1 expression • BRCA mutation
    |
    SKL27969
    over2years
    Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients (clinicaltrials.gov)
    P1/2, N=96, Not yet recruiting, SK Life Science, Inc.
    New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1) • BRCA (Breast cancer early onset)
    |
    PD-L1 expression • BRCA mutation
    |
    SKL27969