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Testing STK-012 for advanced solid tumors

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

PHASE1; PHASE2 · Synthekine · NCT05098132

This study is testing a new treatment called STK-012 to see if it can help people with advanced solid tumors, both on its own and with other therapies.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment364 (estimated)
Ages18 Years and up
SexAll
SponsorSynthekine (industry)
Drugs / interventionspembrolizumab
Locations27 sites (Tucson, Arizona and 26 other locations)
Trial IDNCT05098132 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, phase 1a/1b, multicenter, open-label study evaluating the safety and efficacy of STK-012 as both a standalone treatment and in combination with other therapies for patients with advanced solid tumors. The study includes a dose escalation phase to determine the optimal dosing of STK-012 and a dose expansion phase to further assess its effectiveness in specific tumor types. Participants will be selected based on their tumor type and previous treatment history.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors who have progressed after standard treatments or are intolerant to them.

Not a fit: Patients who have received systemic anti-cancer therapy within 3 weeks prior to the study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar combination therapies, but this specific approach with STK-012 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Selected Inclusion Criteria:

1. Phase 1 \[closed to enrollment\]
2. 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 aberrations for which there is a local standard of care available as front line therapy.

Selected Exclusion Criteria:

1. Phase 1 \[closed to enrollment\]
2. Phase 2 \[open to enrollment\]:

   * Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment
   * Tumor with small cell, neuroendocrine, or sarcomatoid components.
   * Received radiotherapy ≤ 7 days of the first dose of study treatment.
   * Known untreated central nervous system metastases
   * Any history of carcinomatous meningitis

Where this trial is running

Tucson, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced Solid Tumor, Non Small Cell Lung Cancer, Untreated Advanced NSCLC, 1st Line NSCLC

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.