MNPR-101-DFO*-89Zr Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

NCT06980506 | Unknown

• 1 other identifier: IST-00Ca
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Solid Tumor; Solid Tumor, Adult

Keywords

Solid Tumor; PET/CT; urokinase plasminogen activator receptor; uPAR; Zirconium-89 imaging; Positron emission tomography/computed tomography; MNPR-101-DFO*-89Zr; uPAR-positive; Urokinase plasminogen activator receptor-positive; EAP IST-00Cb; Antibody radionuclide conjugate; Monoclonal antibody radionuclide conjugate; Solid tumor imaging

Interventions

MNPR-101-DFO*-89Zr DIAGNOSTIC_TEST

MNPR-101-DFO\*-89Zr is an antibody radionuclide conjugate intended to image solid tumors expressing uPAR.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monopar Therapeutics: lead

Study Sites (1)

Excel Diagnostics & Nuclear Oncology Center

Houston, Texas, 77042, United States

AVAILABLE

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ebrahim S. Delpassand, M.D. Chairman & Medical Director, Nuclear Medicine

  Excel Diagnostics & Nuclear Oncology Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Cork, Therapy Coordinator

CONTACT

+1 713-781-6200; scork@exceldiagnostics.com

Nereyda Sauceda, Therapy Coordinator

CONTACT

+1 713-781-6200; nsauceda@exceldiagnostics.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

US (1)