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Study of STK-012 for Advanced Lung Cancer and Other Cancers

This study is testing a new treatment called STK-012, which is an engineered Interleukin-2 (IL-2) designed to target specific immune cells. It is being studied alone and in combination with other treatments like pembrolizumab (KEYTRUDA®), pemetrexed, and carboplatin. The study is for adults aged 18 and older with advanced solid tumors, including non-small cell lung cancer (NSCLC). For NSCLC, participants must have advanced disease that hasn't been treated with systemic therapy before, and have specific biomarkers like PD-L1 negative or STK11 mutated status. The main goal is to see how safe STK-012 is and what side effects it might cause. The study is currently unclear on its recruitment status.

Study design
This is a Phase 1/2, multicenter, open-label study with a planned enrollment of 364 participants. The Phase 2 portion is randomized, comparing STK-012 combinations to standard care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events (side effects) and serious adverse events for 90 days after their last dose of study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05098132

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Synthekine
~364 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:STK-012pembrolizumab KEYTRUDA®pemetrexedcarboplatin

At a glance

Recruiting sites
38 of 47 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Treatment emergent adverse events (TEAEs)
Measured over From 1st dose of study treatment through 90 days after last dose
+7 more outcomes measured

Conditions

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

Explore related trials

Lung Non-Small Cell CarcinomaSolid NeoplasmSTK11 Gene

Where it's being run

47 sites across 20 states
California6
Spain6
Georgia5
New York4
Ireland4
Massachusetts3
Texas3
Ohio2

Who to contact

Synthekine STK-012-101 Contact
[email protected]
650-606-6319
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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Phase 1a: Treatment emergent adverse events (TEAEs)From 1st dose of study treatment through 90 days after last dose

    Incidence of TEAEs in participants with select advanced solid tumors

  • Phase 1a: Serious adverse events (SAEs)From 1st dose of study treatment through 90 days after last dose

    Incidence of SAEs in participants with select advanced solid tumors

  • Phase 1a: Dose limiting toxicities (DLTs)Cycle 1, Days 1 through 21

    Incidence of DLTs in participants with select advanced solid tumors

  • Phase 1a: DeathsFrom 1st dose of study treatment until death, up to 4 years

    Incidence of death in participants with select advanced solid tumors

  • Phase 1b: TEAEs at the RP2DFrom 1st dose of study treatment through 90 days after last dose

    Incidence of TEAEs at the recommended phase 2 dose (RP2D) in participants with select advanced solid tumors

  • Phase 1b: SAEs at the RP2DFrom 1st dose of study treatment through 90 days after last dose

    Incidence of SAEs at the RP2D in participants with select advanced solid tumors

  • Phase 1b: Deaths at the RP2DFrom 1st dose of study treatment until death, up to 4 years

    Incidence of death at the RP2D in participants with select advanced solid tumors

  • Phase 2: Overall response rate (ORR) in Arm A versus Arm CFrom randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years

    To compare the ORR in 1L NSQ NSCLC (PD-L1\<1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per BICR.