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

Study Identifier:
STK-012-101
CT.gov Identifier:
NCT05098132
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To assess the safety, efficacy and PK of STK-012 as monotherapy and in combination with pembrolizumab in patients with selected advanced solid tumors. To evaluate the safety, pharmacokinetics, immunogenicity, preliminary efficacy, and pharmacodynamics of STK-012 as monotherapy and in combination with pembrolizumab. Phase Ib: to evaluate STK-012 as monotherapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types, including renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC). Longitudinal blood samples at pretreatment, peak (Day8) and trough (Day21) of dosing cycles 1–3 were analyzed for STK-012 pharmacokinetics (PK), cytokines, and effects on immune cells. T-cell clonality was analyzed by TCR- sequencing pre/post a single dose of STK-012 (quantifying >10-fold expanding clones).

To investigate the safety and efficacy of STK-012 in combination with standard dose pembrolizumab and chemotherapy vs. the safety and efficacy of standard dose pembrolizumab and chemotherapy in patients with first-line, PD-L1 negative NSQ NSCLC.

To evaluate the safety, pharmacokinetics, immunogenicity, pharmacodynamics, and antitumor activity of STK-012 as monotherapy and in combination in subjects with advanced solid tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Non-Small Cell Lung Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Participant Group/Arm:
    • Read More
  • Drug: AACR 2022: Patients received STK-012 monotherapy and in combination with pembrolizumab. STK-012 will be dosed SQ weekly, and pembrolizumab will be dosed IV every 3 weeks. During Phase 1a, subjects are enrolled in a 3+3 dose escalation to STK-012 as monotherapy (QW or Q3W) or STK-012 + pembrolizumab (Q3W) followed by Phase 1b expansions.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Selected Inclusion Criteria:
    • Phase 1 [closed to enrollment]Phase 2 [open to enrollment]: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.Tumor is PD-L1 negative (TPS <1%) by local testing.No known actionable EGFR, ALK, ROS1, or other actionable genomic a
    Exclusion criteria
    • Selected Exclusion Criteria:
    • Phase 1 [closed to enrollment]Phase 2 [open to enrollment]:Prior immune checkpoint inhibitor (anti-PD[L]1 and/or anti-CTLA-4) treatmentTumor with small cell, neuroendocrine, or sarcomatoid components.Received radiotherapy ≤ 7 days of the first dose of study treatment.Known untreated central nervous system metastasesAny history of carcinomatous meningitis

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START La Rioja
    Logroño, La Rioja, Spain, 26006
    Investigator
    Maria de Miguel
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer
    Location
    START Dublin
    Dublin, Ireland, D07 R2WY
    Investigator
    Austin Duffy
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer