Clinical Trial Details
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
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 or STK11 mutated, non-squamous, non-small cell lung cancer.
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
Selected Inclusion Criteria:
- Phase 1: Selected advanced solid tumors
- 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 meningitis
