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Phase 1Recruiting

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

Sponsored by Synthekine

About 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.

Phase 1: The phase 1a portion is a dose escalation study to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion is a dose expansion study to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types. Phase 2: The phase 2 portion is a randomized, open label study to evaluate STK-012 at two dose levels 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. Subjects in the randomized Phase 2 portion (Part G) will be randomized 1:1:1 and stratified by tumor PD-L1 expression and STK11 mutation status.

Where this study is enrolling (4)

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia

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  • University of Chicago

    Chicago, Illinois

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  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania

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  • Oncology Consultants

    Houston, Texas

    Call 855-827-9525

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Who can participate

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

Exclusion criteria

  • ✕2\. Phase 2:
  • ✕Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment
  • ✕Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components).
  • ✕Received radiotherapy ≤ 7 days of the first dose of study treatment.
  • ✕Known active central nervous system metastases
  • ✕Any history of carcinomatous meningitis

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.