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.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Phase 1a: Treatment emergent adverse events (TEAEs)
Timeframe: From 1st dose of study treatment through 90 days after last dose
Phase 1a: Serious adverse events (SAEs)
Timeframe: From 1st dose of study treatment through 90 days after last dose
Phase 1a: Dose limiting toxicities (DLTs)
Timeframe: Cycle 1, Days 1 through 21
Phase 1a: Deaths
Timeframe: From 1st dose of study treatment until death, up to 4 years
Phase 1b: TEAEs at the RP2D
Timeframe: From 1st dose of study treatment through 90 days after last dose
Phase 1b: SAEs at the RP2D
Timeframe: From 1st dose of study treatment through 90 days after last dose
Phase 1b: Deaths at the RP2D
Timeframe: From 1st dose of study treatment until death, up to 4 years
Synthekine STK-012-101 Contact
Phase 2: Overall response rate (ORR) in Arm A versus Arm C
Timeframe: From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years