NCT06980519

MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

Treatment of Patients With Solid Tumor Cancers Via Intermediate-Size Patient Population Expanded Access Investigational New Drug (IND)

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Monopar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of this Expanded Access Program (EAP) is to allow use of the investigational therapeutic agent, MNPR-101-PCTA-177Lu, for treatment of urokinase plasminogen activator receptor (uPAR)-positive solid tumors identified via positron emission tomography / computed tomography (PET/CT) with investigational imaging agent MNPR-101-DFO\*-89Zr.

Detailed description

This EAP will enroll patients with uPAR-positive solid tumor cancer confirmed by prior PET/CT imaging with MNPR-101-DFO\*-89Zr (EAP IST-00Ca). Eligible patients will be treated with 1 cycle (as 2 fractionated doses) of investigational therapy, MNPR-101-PCTA-177Lu, at 1 of 4 planned dose levels. All enrolled patients will receive active treatment. Dosing of patients will begin at the lowest planned dose level. After 2 patients are dosed at a level, the next 2 patients may receive the next higher dose level, the same dose level, or a lower dose level, based upon the nature and severity of adverse reactions (side effects). The safety, tolerability, and potential antitumor effects (radiologic response) of MNPR-101-PCTA-177Lu will be evaluated over 12 weeks after dosing. The amount of radioactivity in blood samples will be checked over 4 weeks post dose. Patient survival will be followed up 6 months after the last dose received.

Conditions

• Cancer
• Solid Tumor
• Solid Tumor Cancer
• Oncology
• uPAR-positive Solid Tumor
• Urokinase Plasminogen Activator Receptor-positive Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	MNPR-101-PCTA-177Lu	MNPR-101-PCTA-177Lu is a monoclonal antibody-radionuclide conjugate intended to target and deliver radioactivity to solid tumors expressing uPAR.

Timeline

• First posted: 2025-05-20
• Last updated: 2025-05-22

Locations

1 site across 1 country: United States