Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
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.
Checked against the public recordLast updated Jul 21, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Synthekine
- Interventions being studied
- Drug: STK-012; Drug: pembrolizumab KEYTRUDA®; Drug: pemetrexed; Drug: carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Arizona Cancer CenterTucson, Arizona
- Beverly Hills Cancer CenterBeverly Hills, California
- Providence Medical FoundationFullerton, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- Cedars SinaiLos Angeles, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- UCLA Hematology/Oncology - Santa MonicaSanta Monica, California
- Yale New Haven Hospital, Yale Cancer CenterNew Haven, Connecticut
- Georgetown UniversityWashington D.C., District of Columbia
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
- University of ChicagoChicago, Illinois
- University of MarylandBaltimore, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 21, 2026. Always confirm current availability with the study team.