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.
Locations
47Georgia
LTD High Technology Hospital Medcenter6000, Batumi Georgia
Caraps Medline, Ltd (JSC VIAN)0159, Tbilisi Georgia
Institute of Clinical Oncology (ICO)0159, Tbilisi Georgia
Israel Georgian Medical Research Clinic Healthycore0159, Tbilisi Georgia
Sponsors and collaborators
Synthekine
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov