Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375564
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-04-17
Brief Title:
Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression
Sponsor:
The First Affiliated Hospital of Xiamen University
Organization:
The First Affiliated Hospital of Xiamen University
Study Overview
Official Title:
An Open-Label Non-Randomized Single-Center Investigator-Initiated Trial to Determine the Effectiveness of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression
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 an open-label non-controlled non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD
Detailed Description:
Integrin αvβ3 is highly expressed in some tumor cells and neovascularization which is an ideal target for diagnosis and treatment of solid tumors 177Lu-AB-3PRGD2 is a kind of new drug based on independent research and development in China providing an effective target for the treatment of tumors All patients underwent whole-body 68Ga-RGD PETCT for selection and accepted intravenous injection with a fixed dose of 296 GBq 80 mCi of 177Lu-AB-3PRGD2 within one week Treatment is planned for up to 4 cycles and the time interval between cycles is 6 weeks The primary endpoint assessed the preliminary treatment efficacy of 177Lu-AB-3PRGD2 used for radioligand therapy in patients with various advanced tumors The secondary endpoint evaluates the safety of 177Lu-AB-3PRGD2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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