Testing STK-012 alone and with other drugs for advanced lung and other cancers
Tests STK-012, alone or with chemotherapy and pembrolizumab, in adults with advanced lung cancer.
Plain-language title generated from the registry record
Registry title: Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
Key facts
- Where
- Batumi and Tbilisi, GeorgiaSee the 4 sites
- Phase
- Phase 1/2
Where in Georgia
- LTD High Technology Hospital MedcenterBatumi, GeorgiaTaking people
- Caraps Medline, Ltd (JSC VIAN)Tbilisi, GeorgiaTaking people
- Institute of Clinical Oncology (ICO)Tbilisi, GeorgiaTaking people
- Israel- Georgian Medical Research Clinic HealthycoreTbilisi, GeorgiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Synthekine
- Trial code
- NCT05098132EU 2025-522632-14-00
- Record updated
- 29 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
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:; 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.