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Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors

Study Status Open To Accrual
National Clinical Trial Identifier NCT05098132
Phase I/II
  • Full Title

    A Phase Ia/Ib Study to Evaluate the Safety and Tolerability of STK-012 as a Single Agent and in Combination Therapy in Subjects with Selected Advanced Solid Tumors

  • Purpose
    This is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of
    STK-012 as monotherapy and in combination with pembrolizumab in patients with selected
    advanced solid tumors.
  • Objective
    The phase 1a portion of the study is standard 3+3 dose escalation design to evaluate STK-012
    as monotherapy and in combination with pembrolizumab in patients with selected solid tumors
    who have progressed after standard of care treatments. The phase 1b portion of the study
    includes dose expansions to evaluate STK-012 as monotherapy and in combination with
    pembrolizumab at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.
  • Eligibility
    Selected Inclusion Criteria

    1. Patients must have selected tumor types and must have progressed after standard of
    care treatment, or be intolerant to treatment, or refused standard treatment.

    2. Patients must be amenable to a fresh tissue biopsy, unless medically contraindicated.

    3. Patients with central nervous system (CNS) metastases must have been treated and be
    asymptomatic.

    Selected Exclusion Criteria:

    1. Received systemic anti-cancer therapy within 3 weeks of the first dose of study
    treatment or small molecule kinase inhibitors within 6 elimination half-lives of the
    first dose of study treatment.

    2. Received radiotherapy within 2 weeks of the first dose of study treatment.

    3. Received prior IL-2-based or IL-15-based cytokine therapy.
  • Resources & Links
  • Interested in this Trial?
    If you are interested in participating in this study, call The JamesLine at 800-293-5066 to make an appointment with the principal investigator listed or ask your doctor if you are eligible for this study.

Trial Information

Protocol Number:OSU-23369
Gender:All
Disease Groups:Genitourinary, Thoracic