NCT05098132

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

About the 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 or STK11 mutated, non-squamous, non-small cell lung cancer.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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.

EXCLUSION CRITERIA

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