Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366451
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-04-03
Brief Title:
PBI-MST-01 NCT04541108 Substudy AZN-05 Intratumoral Microdosing of Rilvegostomig Volrustomig and Sabestomig in HNSCC
Sponsor:
Presage Biosciences
Organization:
Presage Biosciences
Study Overview
Official Title:
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of Rilvegostomig Volrustomig and Sabestomig
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center open-label Phase 0 substudy designed to evaluate the localized pharmacodynamics PD of rilvegostomig volrustomig and sabestomig within the tumor microenvironment TME when administered intratumorally in microdose quantities via the CIVO device in patients presenting with Head and Neck Squamous Cell Carcinoma HNSCC with a surface accessible lesion who are scheduled for tumor andor regional node dissection as part of their standard treatment PD effects due to injected investigational agents will be compared to those elicited by pembrolizumab alone which will also be injected in microdose quantities via the CIVO device
Detailed Description:
The CIVO Microdose Injection Device MID simultaneously delivers multiple drugs and drug combinations Up to 8 each in microdose amounts into a single patient tumor and enables comparisons of the resulting biomarker responses that occurred while that tumor was still in the native microenvironment AstraZeneca is developing three novel assets rilvegostomig volrustomig and sabestomig all of which are bispecific monoclonal antibodies designed to stimulate antitumor immunity In this Phase 0 clinical trial the PD effects of these investigational assets in the TME of patients presenting with HNSCC will be evaluated These investigational assets will be injected alone in microdose quantities at tumor sites in HNSCC patients Pembrolizumab also used therapeutically in this patient population will be included in the CIVO injection array administered as a single agent The CIVO-injected portion of the tissue will be analyzed for localized response at sites of drug exposure in the TME
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PBI-MST-01 | OTHER | Presage Biosciences | None |