Overview

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

Selected Inclusion Criteria:

1. Phase 1 \[closed to enrollment\]
2. 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.

Selected Exclusion Criteria:

1. Phase 1 \[closed to enrollment\]
2. Phase 2 \[open to enrollment\]:
   • Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment
   • Tumor with small cell, neuroendocrine, or sarcomatoid components.
   • Received radiotherapy ≤ 7 days of the first dose of study treatment.
   • Known untreated central nervous system metastases
   • Any history of carcinomatous meningitis