RecruitingPhase 1NCT06326502

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

An Open-label, Multi-center, Dose-escalation Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ETN101 in Patients With Advanced Hepatocellular Carcinoma


Sponsor

Etnova Therapeutics Corp.

Enrollment

50 participants

Start Date

Feb 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

ETN101 is a multiple tyrosine kinase inhibitor (mTKI) targeting fms-like tyrosine kinase 3 (FLT3), receptor tyrosine kinase (KIT), vascular endothelial growth factor receptor 2 (VEGFR2), and platelet-derived growth factor receptor beta. Both in vitro and in vivo studies showed that ETN101 treatment/administration inhibited cancer cell survival and proliferation. In animal models, ETN101 had antitumor activity when administered to animals that did not respond to conventional targeted anticancer agents.


Eligibility

Min Age: 19 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called ETN101 — a multi-target tyrosine kinase inhibitor — for people with advanced liver cancer (hepatocellular carcinoma, or HCC) that has progressed despite standard treatments. The drug is designed to block multiple signaling pathways that tumors use to grow and spread. **You may be eligible if...** - You are 19 or older - You have advanced liver cancer confirmed by imaging or biopsy - Your cancer has progressed on or you cannot tolerate standard therapies - Your cancer is classified as BCLC stage B or C - Your liver function is relatively preserved (Child-Pugh score of A) - You have at least one measurable tumor that has not been previously treated locally **You may NOT be eligible if...** - You have very poor liver function - You have certain heart problems or poorly controlled blood pressure - You are pregnant or breastfeeding - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGETN101

Oral administration


Locations(2)

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06326502


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