Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614855
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
A Phase IB 2 Dose Trial of IRS-1 HSV C134 IND 17296 Administered Intratumorally in Patients with Recurrent Malignant Glioma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IB 2 Dose Trial of IRS-1 HSV C134 IND 17296 Administered Intratumorally in Patients with Recurrent Malignant Glioma
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 purpose of this study is to determine how safe and how well-tolerated the experimental study drug C134 is when administered twice into the brain where the tumor is located This is a Phase IB 2 dosing study All the patients who take part in this study will receive the same type of experimental treatment There is no placebo in this study The patient will receive the dose of C134 administered which will be added in the tumor infiltrated tissue in the area of the resection cavity Anywhere from 4-12 patients are expected to take part in the study the final number will depend on the safety results
Detailed Description:
This study is divided into the following sections also called phases the Initial Screening Phase Initial Treatment Phase Initial Treatment Follow-up Phase 2nd Treatment Screening Phase 2nd Treatment Phase 2nd Treatment Follow-up Phase Before the subject can participate in the study tests will be performed to make sure that the subject qualifies for the study This is called the Initial Screening Phase If the subject qualifies for the study they will then enter the Initial Treatment Phase which is the phase where they will receive the study drug and then enter the Initial Follow-up Phase If there are signs of progression the subject will be entered into the 2nd Treatment Phase
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