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Back|NCT05098132RecruitingUpdated Nov 28, 2025|Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

Official Title

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

Phase

Phase 1/Phase 2

Sponsor

Synthekine

Enrollment

364

Timeline

Jan 2022 → Jan 2029

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, non-squamous, non-small cell lung cancer.

Eligibility Criteria

Inclusion Criteria

1Phase 1 \[closed to enrollment\]
2Phase 2 \[open to enrollment\]:
3Diagnosis of non-small cell lung cancer (NSCLC).
4Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment.
5Non-squamous (NSQ) cell histology.
6No prior systemic therapy for advanced/metastatic NSQ NSCLC.
7Tumor is PD-L1 negative (TPS \<1%) by local testing.
8No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy.