Phase 1 Study of APX-343A Alone or With Pembrolizumab to Evaluate Safety, Dosage, and Early Effects in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are conducting a Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary effectiveness of APX-343A alone and combined with pembrolizumab in adults with advanced solid tumors. This study aims to understand how these treatments work in patients with serious cancer conditions and to find appropriate dosing levels. The study is divided into two parts. Part A involves gradually increasing doses of APX-343A given orally twice daily as a monotherapy, while Part B tests increasing doses of APX-343A combined with pembrolizumab, which is administered intravenously. Both parts focus on patients with advanced solid tumors, with the goal of determining safe and tolerable doses for future research. Participants will be monitored from enrollment through treatment and up to 90 days after treatment ends to assess safety and tolerability. Researchers will also measure how the body processes APX-343A over three weeks and track tumor response for about a year using imaging criteria. The study requires patients to provide tumor tissue samples and undergo regular evaluations, including physical exams and lab tests, to ensure safety and gather detailed information on treatment effects.

A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors