Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102525
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-06-23
Brief Title:
A Study to Evaluate the Safety Tolerability and Efficacy of RZ-001 With Valganciclovir VGCV in Subjects With Glioblastoma
Sponsor:
Rznomics Inc
Organization:
Rznomics Inc
Study Overview
Official Title:
A Phase 12a Open-label Multicenter Dose Escalation and Dose Expansion Study Evaluating the Safety Tolerability and Efficacy of RZ-001 in Combination With Valganciclovir in Subjects With Glioblastoma
Status:
RECRUITING
Status Verified Date:
2024-08
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 is a Phase 12a open-label study to evaluate the safety tolerability immunogenicity and preliminary clinical activity of RZ-001 administered in combination with VGCV in subjects with hTERT-positive GBM
Detailed Description:
The study consists of 2 parts a dose-escalation part Part 1 and a dose-expansion part Part 2
Part 1 consists of dose escalation exploring MTDRP2D for intratumoral IT injection
Part 2 will consist of dose expansion exploring clinical activity for the optimal fixed dose based on the results of Part 1
Part 1 consists of dose escalation exploring MTDRP2D for intratumoral IT injection
Part 2 will consist of dose expansion exploring clinical activity for the optimal fixed dose based on the results of Part 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None