Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389123
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Brief Title:
Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
A Novel Molecularly Targeted Theranostic Approach Via the αvβ6 Integrin for the Detection and Treatment of Metastatic Carcinomas
Status:
RECRUITING
Status Verified Date:
2024-04
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 Phase I study to evaluate the safety and efficacy of the 68GaGa DOTA-5G and 177LuLu DOTA-ABM-5G theranostics pair in patients with metastatic cancer
Detailed Description:
This is a Phase I study to evaluate the safety and efficacy of the 68GaGa DOTA-5G and 177LuLu DOTA-ABM-5G theranostics pair in patients with metastatic cancer 68GaGa DOTA-5G PETCT will be used to identify and stratify patients eligible for and most likely to respond to the 177LuLu DOTA-ABM-5G therapy Up to 40 patients will be enrolled over a 36-month period with metastatic cancer with a life expectancy of at least 3 months who demonstrate disease progression after at least 1 prior treatment for metastatic disease and have available archival tissue
We hypothesize that a 68GaGa DOTA-5G will detect lesions in patients with metastatic cancer b the theranostic pair 68GaGa DOTA-5G 177LuLu DOTA-ABM-5G will be safe and well tolerated and c a therapeutic response will be achieved with a single dose of 177LuLu DOTA-ABM-5G
We hypothesize that a 68GaGa DOTA-5G will detect lesions in patients with metastatic cancer b the theranostic pair 68GaGa DOTA-5G 177LuLu DOTA-ABM-5G will be safe and well tolerated and c a therapeutic response will be achieved with a single dose of 177LuLu DOTA-ABM-5G
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