Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583993
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α srRNA in Treating Advanced ICC 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 Advanced Intrahepatic Cholangiocarcinoma
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:
The goal of this investigator-initiated a single-arm open-label pilot study is to investigate the safety tolerability and efficacy of intravenous HNF4α srRNA treatment in subjects with advanced Intrahepatic Cholangiocarcinoma ICC
Condition of disease advanced intrahepatic cholangiocarcinoma Intervention HNF4α srRNA will be administered intravenously for the treatment of ICC The dosing regimen is planned for a second dose 14 3 days post-initial treatment followed by subsequent treatments every 28 7 days with adjustments made based on patient tolerance and therapeutic response This is a dose escalation assay employing a i33 design to assess escalating HNF4α srRNA dosages 25 μg 50 μg and 100 μg Post-initial dose a 14-day dose-limiting toxicities DLT observation will evaluate tolerability and safety guiding dose adjustments or selection of the Recommended Dose RD for the expansion phase Cohorts may include up to 9 participants adjusted for safety
Drug HNF4α srRNA a drug specifically designed to target liver cancer cells and facilitate the expression of HNF4α
Condition of disease advanced intrahepatic cholangiocarcinoma Intervention HNF4α srRNA will be administered intravenously for the treatment of ICC The dosing regimen is planned for a second dose 14 3 days post-initial treatment followed by subsequent treatments every 28 7 days with adjustments made based on patient tolerance and therapeutic response This is a dose escalation assay employing a i33 design to assess escalating HNF4α srRNA dosages 25 μg 50 μg and 100 μg Post-initial dose a 14-day dose-limiting toxicities DLT observation will evaluate tolerability and safety guiding dose adjustments or selection of the Recommended Dose RD for the expansion phase Cohorts may include up to 9 participants adjusted for safety
Drug HNF4α srRNA a drug specifically designed to target liver cancer cells and facilitate the expression of HNF4α
Detailed Description:
None
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