Expanded Access Program for MNPR-101-DFO*-89Zr in Patients with Solid Tumor Cancer

Sponsor: Monopar Therapeutics

Expanded Access
Sponsor score: 60

ClinicalTrials ID:NCT06980506

This program allows patients with solid tumor cancer to use an investigational imaging agent, MNPR-101-DFO*-89Zr, to help detect cancer activity through PET/CT scans. The imaging agent targets a specific receptor that is often more active in tumors than in normal tissue.

Patient Parameters

Program Overview

The goal of this Expanded Access Program (EAP) is to provide patients with solid tumor cancer access to an investigational imaging agent called MNPR-101-DFO*-89Zr. This agent is used with PET/CT scans to non-invasively detect the presence of a receptor known as uPAR, which is often more active in cancerous tumors compared to normal tissue. This detection can help determine if patients are eligible for further treatment with another investigational agent in a separate program.

Description

In this program, adult patients with solid tumor cancer will receive a dose of the imaging agent MNPR-101-DFO*-89Zr. After 3 to 5 days, they will undergo a PET/CT scan to see if the agent binds to the uPAR receptor in their tumors. This binding is important because it can indicate whether the patient might benefit from another investigational treatment in a different program. The safety of the imaging agent will be monitored, and the level of radioactivity in blood samples will be checked to ensure it is safe for patients.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic solid tumor cancer that does not respond to existing treatments, or for which no standard treatment is available.
  • Be able to understand and willing to sign a consent form agreeing to participate in the program.

Exclusion Criteria

  • Have ongoing severe side effects from previous cancer treatments.
  • Have received any radiopharmaceutical or investigational treatments within the last 4 weeks or longer, depending on the treatment's half-life.
  • Have impaired organ function, especially in the bone marrow, liver, kidneys, or heart, based on specific medical tests.
  • Have other serious non-cancerous diseases or conditions that could affect the study's goals, patient safety, or ability to follow the program.

Locations

FACILITYZIPCITYSTATE
Excel Diagnostics & Nuclear Oncology Center77042HoustonTexas

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