MNPR-101-DFO*-89Zr Expanded Access Program (EAP) for Patients With Solid Tumor Cancer
Sponsor: Monopar Therapeutics
ClinicalTrials ID:NCT06980506
This Expanded Access Program allows adult patients with refractory or untreatable solid tumors to receive the investigational imaging agent MNPR-101-DFO*-89Zr. Following administration, PET/CT imaging assesses uPAR binding to determine eligibility for further treatment. Eligibility requires confirmed advanced solid tumor cancer and informed consent. Safety and radioactivity levels will be monitored.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
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.
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Excel Diagnostics & Nuclear Oncology Center | 77042 | Houston | Texas |
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