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    Cancer Clinical Trials

    Phase 1b expansion of STK-012, a first-in-class IL-2R α/β partial agonist cytokine, in combination with standard of care treatment (pembrolizumab + pemetrexed + carboplatin) in first line non-squamous PD-L1 negative NSCLC

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    What is the purpose of this study?

    This is a phase 1/2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative or STK11 mutated, non-squamous, non-small cell lung cancer.

    Eligibility

    Selected Inclusion Criteria:

    1. Phase 1: Selected advanced solid tumors

    2. Phase 2:

      • Diagnosis of non-small cell lung cancer (NSCLC).

      • Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment.

      • Non-squamous (NSQ) cell histology.

      • No prior systemic therapy for advanced/metastatic NSQ NSCLC.

      • Must have a tumor that meets at least one of the following criteria on local testing:

        • PD-L1 negative (TPS <1%), OR;
        • STK11 mutated on tumor tissue or ctDNA

      • No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy.

    Selected

    Where can I participate?

    Hoag Hospital Newport Beach
    1 Hoag Dr
    Newport Beach, CA 92663


    Lauren Wagner

    lauren.wagner@hoag.org


    More about this Clinical Trial

    What is the full name of this Clinical Trial?

    A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects With Front-line Advanced NSCLC and Other Selected Indications

    • Disease Type/ConditionSolid Tumor, Adult, Lung Cancer
    • Principal InvestigatorAlain Mita, MD
    • Co-InvestigatorsMonica M. Mita, MD, Carlos R. Becerra, MD, Yaser Homsi, MD, Simon Khagi, MD, David J. Benjamin, MD
    • Age GroupAdult, Older Adult
    • PhaseII
    • ClinicalTrials.gov IDNCT05098132

    Hoag Family Cancer Institute

    Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.

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