Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
Study NCT ID:
NCT06980506
Status:
AVAILABLE
Last Update Posted:
2025-05-22
First Post:
2025-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MNPR-101-DFO*-89Zr Expanded Access Program (EAP) for Patients With Solid Tumor Cancer
Sponsor:
Monopar Therapeutics
Organization:
Study Overview
Official Title:
Imaging of Patients With Solid Tumor Cancer Via Intermediate-Size Patient Population Expanded Access Investigational New Drug (IND)
Status:
AVAILABLE
Status Verified Date:
2025-05
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:
The purpose of this Expanded Access Program (EAP) is to allow use of the investigational imaging agent, MNPR-101-DFO\*-89Zr, with positron emission tomography/computed tomography (PET/CT) imaging, to non-invasively detect the presence of urokinase plasminogen activator receptor (uPAR) binding in solid tumors. uPAR binding is higher in tumors compared to normal tissue in some cancers.
Detailed Description:
Imaging agent MNPR-101-DFO\*-89Zr will be dosed to adult patients diagnosed with solid tumor cancer followed 3 to 5 days later by PET/CT imaging. The result will determine if there is sufficient uPAR binding, as assessed by the Investigator, to support administration of the companion intervention MNPR-101-PCTA-177Lu in a separate expanded access program (EAP IST-00Cb). The safety of MNPR-101-DFO\*-89Zr will be evaluated as will the amount of radioactivity present in blood samples.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: