This is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and expansion study designed to determine the maximum tolerated dose and recommended phase 2 dose(s) and evaluate the safety and tolerability, pharmacokinetics, and antineoplastic activity of escalating oral doses of TNG260 when administered with a standard dose of pembrolizumab in participants with locally advanced or metastatic STK11 mutated solid tumors.
The goal of this interventional clinical trial is to learn about TNG260, a CoREST inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with a known STK11 mutation.~The main question[s] it aims to answer are:~the recommended dose for Phase 2~to evaluate the safety and tolerability of the combination therapy~to determine the pharmacokinetics of TNG260~to evaluate the initial antineoplastic activity~Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.