Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374485
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-11
Brief Title:
Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment
Sponsor:
Lees Pharmaceutical Limited
Organization:
Lees Pharmaceutical Limited
Study Overview
Official Title:
A Phase I Single-arm Open-label Dose-escalation Safety and Pharmacokinetic Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This study is a Phase I dose-escalation study of AU409 in advanced hepatocellular carcinoma patients who failed standard treatment A 33 dose-escalation design will be utilized to gradually increase the dose of AU409 aiming to assess the safety tolerability pharmacokinetics and preliminary antitumor efficacy of multi-dose AU409 in patients with advanced HCC
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None