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, non-squamous, non-small cell lung cancer.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Phase 2: Overall response rate (ORR) in Arm A versus Arm C
Synthekine STK-012-101 Contact
Timeframe: From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years