Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365918
Status:
WITHDRAWN
Last Update Posted:
2024-06-10
First Post:
2024-04-10
Brief Title:
Study of VG2025 Delivered Intraperitoneally in Patients with Advanced Solid Tumors with Carcinomatosis
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of VG2025 Delivered Intraperitoneally in Patients with Advanced Solid Tumors with Carcinomatosis
Status:
WITHDRAWN
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Request
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To find the recommended dose of the investigational drug VG2025 that can be given intraperitoneally given directly into the abdominal cavity to participants with advanced solid tumors
Detailed Description:
Primary Objectives
1 To assess safety and tolerability of VG2025 following IP administration
2 To determine the Maximum Tolerated Dose MTD and the Recommended Phase 2 Dose RP2D of IP VG2025
Secondary Objectives
1 To estimate progression free survival
2 To characterize the biodistribution or shedding profile of detectable VG2025 DNA in tumor biopsy samples IP fluid and blood
3 To evaluate IL-12 IL-15 and other cytokine levels in tumor biopsy samples IP fluid and blood
4 To evaluate tumor CEA expression
5 To evaluate the objective response rate ORR and clinical benefit rate CBR of IP administration of VG2025 in the overall patient population and by dose level
6 To characterize changes in the IP and tumor immune microenvironment in response to treatment
7 To correlate circulating tumor DNA ctDNA with disease status
1 To assess safety and tolerability of VG2025 following IP administration
2 To determine the Maximum Tolerated Dose MTD and the Recommended Phase 2 Dose RP2D of IP VG2025
Secondary Objectives
1 To estimate progression free survival
2 To characterize the biodistribution or shedding profile of detectable VG2025 DNA in tumor biopsy samples IP fluid and blood
3 To evaluate IL-12 IL-15 and other cytokine levels in tumor biopsy samples IP fluid and blood
4 To evaluate tumor CEA expression
5 To evaluate the objective response rate ORR and clinical benefit rate CBR of IP administration of VG2025 in the overall patient population and by dose level
6 To characterize changes in the IP and tumor immune microenvironment in response to treatment
7 To correlate circulating tumor DNA ctDNA with disease status
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03236 | OTHER | NCI-CTRP Clinical Registry | None |