Study of the PARG Inhibitor ETX-19477 Taken Orally to Treat Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating ETX-19477, a novel reversible small molecule inhibitor of poly ADP ribose glycohydrolase PARG, in patients with advanced solid tumors. This two-part, open-label, multicenter study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of ETX-19477. The study focuses on tumors characterized by replication stress and DNA damage response pathways, targeting a vulnerability in cancer cells. The study includes two parts Part 1 involves dose escalation where participants receive daily oral doses of ETX-19477 to determine the maximum tolerated dose or recommended phase 2 dose. Part 2 is a dose expansion phase where participants receive the determined dose level. Participants are assigned to a dose level in each part. The study does not use placebo and is non-randomized. Participants will undergo assessments to monitor safety and side effects, as well as pharmacokinetic measurements of the drug concentration in the blood over time. Researchers will also evaluate tumor responses using standardized criteria over up to two years. The primary outcome is safety and tolerability measured over six months. Additional evaluations include pharmacokinetic profiles at three months and anti-tumor activity measures such as response rates and disease control over two years. The study is expected to continue until December 2026.

A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies