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    DRUG:

    nanrilkefusp alfa (SOT101)

    i
    Other names: SO-C101, SOT101, SO C101, RLI15, RLI 15, ATL301 with receptor-linked interleukin-15 (RLI), ATL-302, CYP-0150, CYP 0150
    Associations

    News

    Trials
    Company:
    Sotio
    Drug class:
    IL-2 stimulant, IL-15 superagonist
    Related drugs:
    Associations

    News

    Trials
    10ms
    Nanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers. (PubMed, Cell Rep Med)
    It had a favorable safety profile when administered subcutaneously on days 1, 2, 8, and 9 of each 21-day cycle as monotherapy (0.25-15 μg/kg) or combined (1.5-12 μg/kg) with the anti-PD-1 pembrolizumab (200 mg). The most frequent treatment-emergent adverse events were pyrexia, injection site reactions, and chills. Furthermore, early clinical efficacy was observed, including in immune checkpoint blockade-resistant/refractory patients.
    Journal
    |
    CD8 (cluster of differentiation 8) • IL15 (Interleukin 15)
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    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    11ms
    AURELIO-03: Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=115, Terminated, SOTIO Biotech AG | N=200 --> 115 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Aug 2024; Due to lack of efficacy shown at the time of the interim analysis.
    Enrollment change • Trial termination • Trial primary completion date
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    12ms
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=166, Terminated, SOTIO Biotech AG | Active, not recruiting --> Terminated; Due to lack of expected efficacy shown at the time of the interim analysis
    Trial termination • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    1year
    AURELIO-03: Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=200, Active, not recruiting, SOTIO Biotech AG | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    over1year
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=166, Active, not recruiting, SOTIO Biotech AG | Trial completion date: Dec 2025 --> Nov 2024 | Trial primary completion date: Sep 2025 --> Aug 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    over1year
    AURELIO-05: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer (clinicaltrials.gov)
    P2, N=16, Terminated, SOTIO Biotech AG | N=52 --> 16 | Trial completion date: Nov 2024 --> Jun 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2024 --> Mar 2024; Due to lack of efficacy shown at the time of the interim analysis.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)
    over1year
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=166, Active, not recruiting, SOTIO Biotech AG | N=320 --> 166 | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Sep 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    over1year
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=320, Active, not recruiting, SOTIO Biotech AG | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2023 --> Apr 2025
    Enrollment closed • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    over1year
    AURELIO-03: Study of SO-C101 and SO-C101 in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=200, Active, not recruiting, SOTIO Biotech AG | Trial completion date: Dec 2023 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Aug 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    over1year
    AURELIO-05: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer (clinicaltrials.gov)
    P2, N=52, Active, not recruiting, SOTIO Biotech AG | Recruiting --> Active, not recruiting | Trial completion date: Nov 2025 --> Nov 2024 | Trial primary completion date: Nov 2025 --> Aug 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    RAS wild-type
    |
    Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)
    over2years
    AURELIO-05: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer (clinicaltrials.gov)
    P2, N=64, Recruiting, SOTIO Biotech AG | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    CRP (C-reactive protein)
    |
    RAS wild-type
    |
    Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)
    3years
    AURELIO-05: A Study of SOT101 in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer (clinicaltrials.gov)
    P2, N=64, Not yet recruiting, SOTIO Biotech AG
    New P2 trial • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • CRP (C-reactive protein)
    |
    EGFR mutation • RAS mutation • RAS wild-type
    |
    Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)