MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer
brief 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.
official title
Treatment of Patients With Solid Tumor Cancers Via Intermediate-Size Patient Population Expanded Access Investigational New Drug (IND)