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