Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326502
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-17
Brief Title:
A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug ETN101 in Advanced Hepatocellular Carcinoma
Sponsor:
Etnova Therapeutics Corp
Organization:
Etnova Therapeutics Corp
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 treatmentadministration 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
Detailed Description:
The study drug ETN101 is an mTKI targeting FLT3 VEGFR2 PDGFR-beta and KIT Based on its preclinical study results the study drug was anticipated to have a potent anticancer effect by blocking the signaling pathway of receptor tyrosine kinases In animal models with subcutaneously transplanted liver cancer cells HepG2 complete remission CR or partial remission PR were observed in animals treated with ETN101 at doses of 2082 mgkg In addition ETN101 82 mgkg induced CR and PR in animals that had not responded to HCC therapies sorafenib and lenvatinib ETN101 10 mgkg was found to have antitumor efficacy as demonstrated by approximately 30 suppression of tumor growth in comparison with a negative control
Overall ETN101 is anticipated to have anticancer activity as a targeted therapy in the treatment of advanced HCC that did not respond to prior therapy or that recurred subsequently and therefore is expected to offer a new treatment opportunity for patients with advanced hepatocellular carcinoma HCC for whom therapeutic options are limited
Therefore this study aims to evaluate the safety tolerability pharmacokinetics PK and efficacy of ETN101 and to determine the maximum tolerated dose MTD and recommended phase 2 dose RP2D of ETN101 in patients with HCC who previously had second- or further-line anticancer treatment
Overall ETN101 is anticipated to have anticancer activity as a targeted therapy in the treatment of advanced HCC that did not respond to prior therapy or that recurred subsequently and therefore is expected to offer a new treatment opportunity for patients with advanced hepatocellular carcinoma HCC for whom therapeutic options are limited
Therefore this study aims to evaluate the safety tolerability pharmacokinetics PK and efficacy of ETN101 and to determine the maximum tolerated dose MTD and recommended phase 2 dose RP2D of ETN101 in patients with HCC who previously had second- or further-line anticancer treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None