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Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 meningitisAbout the 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.
What is being tested
- STK-012 (drug)
- pembrolizumab KEYTRUDA® (drug)
- pemetrexed (drug)
- carboplatin (drug)
Sponsor: Synthekine · Participants: 364 · Started: Jan 25, 2022
Contact the study team
- Synthekine STK-012-101 Contact · Phone: 650-606-6319
Official record on ClinicalTrials.gov — NCT05098132
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.