The purpose of this Expanded Access Program (EAP) is to allow use of the investigationalimaging agent, MNPR-101-DFO*-89Zr, with positron emission tomography/computed tomography(PET/CT) imaging, to non-invasively detect the presence of urokinase plasminogenactivator receptor (uPAR) binding in solid tumors. uPAR binding is higher in tumorscompared to normal tissue in some cancers.
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.
Diagnostic Test: MNPR-101-DFO*-89Zr
MNPR-101-DFO*-89Zr is an antibody radionuclide conjugate intended to image solid tumors
expressing uPAR.
Key Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor
cancer that is refractory to existing therapy(ies) known to provide clinical
benefit, or for which no standard treatment is available, or is contraindicated
- Ability to understand and willingness to sign a written informed consent document
Key Exclusion Criteria:
- Continuing ≥ Grade 3 adverse reactions from prior systemic therapy (Common
Terminology Criteria for Adverse Events [CTCAE] version 5.0)
- Prior treatment with any radiopharmaceutical or investigational agents within 4
weeks or 5 half-lives, whichever is longer, prior to administration of
MNPR-101-DFO*-89Zr
- Evidence of impaired organ function, particularly bone marrow, liver, kidney, or
heart, according to specific test parameters
- Presence of other serious, non-malignant diseases or any other condition that, in
the opinion of the investigator, could interfere with the objectives of the study,
participant safety, or compliance.
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, United States
Susan Cork, Therapy Coordinator
+1 713-781-6200 - Ext. 3203
scork@exceldiagnostics.com
Nereyda Sauceda, Therapy Coordinator
+1 713-781-6200 - Ext. 3246
nsauceda@exceldiagnostics.com
Ebrahim S. Delpassand, M.D. Chairman & Medical Director, Nuclear Medicine, Principal Investigator
Excel Diagnostics & Nuclear Oncology Center