The purpose of this Expanded Access Program (EAP) is to allow use of the investigationaltherapeutic agent, MNPR-101-PCTA-177Lu, for treatment of urokinase plasminogen activatorreceptor (uPAR)-positive solid tumors identified via positron emission tomography /computed tomography (PET/CT) with investigational imaging agent MNPR-101-DFO*-89Zr.
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.
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.
Key Inclusion Criteria:
- Participated in the Expanded Access Program (EAP) IST-00Ca study
- 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:
- Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or
immunotherapy within 14 days prior to administration of MNPR-101-PCTA-177Lu
- 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 the first
dose of MNPR-101-PCTA-177Lu other than 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