Phase 1 Study to Test Safety and Dosage of ETN101, a Targeted Drug, in Adults With Advanced Liver Cancer Who Have Tried Other Treatments

What this Trial Is About

Researchers are studying ETN101, a multiple tyrosine kinase inhibitor mTKI designed to target specific receptors involved in cancer growth, including FLT3, KIT, VEGFR2, and PDGFR-beta. This investigational drug has shown promising anticancer effects in laboratory and animal studies, including cases where standard liver cancer treatments did not work. The study focuses on patients with advanced hepatocellular carcinoma HCC who have tried at least two prior anticancer therapies and are seeking new treatment options. The study involves oral administration of ETN101 to patients with advanced HCC. It is an open-label, multi-center, dose-escalation phase 1 trial aiming to determine the maximum tolerated dose MTD, safety, tolerability, pharmacokinetics, and efficacy of ETN101. Patients will receive ETN101, and the study will monitor effects over a period of up to three weeks after starting treatment for dose-limiting toxicities. Participants will be evaluated through regular clinical assessments, laboratory tests, and imaging to measure tumor response and safety. The primary outcome is to observe any dose-limiting toxicities within three weeks of treatment. Patients must meet specific criteria related to liver function, tumor characteristics, and overall health status. This study may last until June 2027, with ongoing monitoring of safety and treatment effects during the trial.

A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma