STX-721-101 is a multicenter, open-label, Phase 1/2 study evaluating the selective inhibitor STX-721 in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations. The primary objective is to characterize the safety and tolerability of STX-721 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Eligible participants are adults with an ECOG performance status of 0-1 who have progressed on or are intolerant to standard-of-care therapies. Molecular eligibility must be confirmed via documented testing (e.g., NGS) during screening. The study follows a dose-escalation design followed by dose-expansion cohorts. Key secondary endpoints include pharmacokinetic parameters and the objective response rate (ORR) according to RECIST 1.1.
This clinical trial is a first-in-human study of a new drug called STX-721 for patients with non-small cell lung cancer. The medication is specifically designed to target tumors with a certain genetic change known as an EGFR Exon 20 insertion mutation. The primary goal of the study is to evaluate the safety and tolerability of the drug and to determine the most effective dose. The study includes adults with locally advanced or metastatic lung cancer whose disease has progressed after previous treatments. Before starting, the specific genetic mutation of the tumor must be confirmed through testing. Participants will take the medication orally while their health is closely monitored by the research team.
