Phase I Study of ATG-037 Alone and Combined with Pembrolizumab to Treat Locally Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, how the body processes and reacts to, and the early effects of ATG-037 alone and combined with Pembrolizumab in adults with locally advanced or metastatic solid tumors. This Phase I study aims to find the best dose and understand treatment impacts on patients whose cancer has progressed despite prior immune checkpoint inhibitor therapy. The trial is open-label, meaning both researchers and participants know the treatments being given, and it includes multiple centers to gather diverse data. The study has two main parts Part I involves dose escalation of ATG-037 given orally once daily initially, then twice daily in cycles of 21 days, followed by combination therapy with Pembrolizumab administered every three weeks for up to about two years. Part II explores ATG-037 given twice daily from the start in combination with Pembrolizumab. Pembrolizumab is given as a fixed 200 mg dose every three weeks. The study includes dose escalation and expansion phases to evaluate different dosing and combinations. Participants will undergo regular monitoring including safety evaluations for adverse events up to one year after the last dose. Researchers will measure drug levels in plasma, immune activity markers, and tumor responses using standard criteria. The study assesses outcomes like dose-limiting toxicities, maximum tolerated dose, and response rates to understand treatment effects. Participants are expected to provide informed consent, meet specific health criteria, and participate in scheduled visits and assessments throughout the treatment and follow-up periods.

A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors