Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSynthekine
About this trial
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 criteria
Qualifiers
Phase 1: Selected advanced solid tumors
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- STK-012
- pembrolizumab KEYTRUDA®
- pemetrexed
- carboplatin
Treatment groups
364 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Synthekine
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov