Phase 1 Study of AU409 to Find Safe Dose and Effects in Adults with Advanced Primary Liver Cancers or Solid Tumors That Have Spread to the Liver

What this Trial Is About

Researchers are evaluating AU409, an RNA transcription modulator, in a phase I trial focused on patients with advanced primary liver cancers or advanced solid tumors that have spread predominantly to the liver. This study aims to determine the safety, side effects, maximum tolerated dose, and recommended phase II dose of AU409. The trial also seeks to assess the drugs preliminary anti-tumor activity and pharmacokinetics in these patients. Participants receive AU409 orally, with dosing guided by a dose-escalation design to find the best dose. During the trial, patients undergo scans such as computed tomography CT or magnetic resonance imaging MRI and have blood samples collected regularly. A subset of patients at higher dose levels will provide liver biopsy samples to study drug concentration and gene expression. The trial includes a dose-escalation period and may have a dose-expansion phase depending on findings. Throughout the study, researchers monitor safety by evaluating adverse events and measure tumor response using radiologic criteria. Pharmacokinetic data are collected at specific times during treatment cycles. The study monitors participants for up to 30 days after treatment ends or until death for safety, with tumor response followed for up to three years. Total participation duration varies by individual patient progress and treatment response.

AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease