Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621173
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Trial Assessing the Safety and Efficacy of Intravenous HNF4α SrRNA for the Treatment of Patients with Metastatic Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is a single-arm open-label exploratory first-in-human clinical study designed to evaluate the safety and tolerability of HNF4α srRNA injection in patients with locally unresectable or metastatic colorectal cancer and to preliminarily explore its effectiveness in treating metastatic colorectal cancer
Detailed Description:
This study will administer HNF4α srRNA via intravenous injection to treat locally unresectable or metastatic colorectal cancer The second treatment will be conducted 14 3 days after the initial treatment with subsequent treatment cycles every 28 7 days the dosing interval will be adjusted based on the tolerability safety and therapeutic effect of the subjects The dose-escalation trial will employ the i33 design method with three dose groups tentatively setting the injection dose of HNF4α srRNA at 25 μg 50 μg and 100 μg per administration and each group is expected to include up to 3 subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None