Phase 1 Study of AST2303 Tablets for Safety and Effectiveness in Adults with Advanced or Metastatic Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early antitumor effects of AST2303 tablets also known as ABK3376 tablets in adults with locally advanced or metastatic non-small cell lung cancer. This phase I clinical trial includes a dose escalation phase and a dose expansion phase, overseen by a safety review committee that evaluates safety, efficacy, and pharmacokinetic data to guide study decisions. Participants receive oral AST2303 tablets once daily on an empty stomach for 21-day cycles. The study tests multiple doses 25 mg, 50 mg, 75 mg, 100 mg, and 125 mg. The trial is non-randomized and open-label, allowing researchers to monitor the effects and pharmacokinetic properties of each dose level. During the study, participants will be closely monitored for adverse events, serious adverse events, and specific safety concerns for up to two years. Researchers will assess tumor response rates, disease control, duration of relief, progression-free survival, and overall survival. Blood samples and tumor tissue may be collected for genetic testing and pharmacokinetic analysis. The study lasts up to two years, including safety and efficacy follow-up.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer