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
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.
• Phase 1 \[closed to enrollment\]
• 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.