MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

NCT06980519 | Unknown

• 1 other identifier: IST-00Cb
• 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 therapeutic agent, MNPR-101-PCTA-177Lu, for treatment of urokinase plasminogen activator receptor (uPAR)-positive solid tumors identified via positron emission tomography / computed tomography (PET/CT) with investigational imaging agent MNPR-101-DFO\*-89Zr.

Conditions

Cancer; Solid Tumor; Solid Tumor Cancer; Oncology; uPAR-positive Solid Tumor; Urokinase Plasminogen Activator Receptor-positive Solid Tumor

Keywords

MNPR-101-PCTA-177Lu; SPECT; SPECT/CT; CT; Radiotherapy; Radiologic response; Single Photon Emission Computed Tomography; Computed Tomography; Monoclonal antibody radionuclide conjugate; Antibody radionuclide conjugate; Lutetium-177; Single Photon Emission Computed Tomography/Computed Tomography; Urokinase plasminogen activator receptor-positive; uPAR-positive; Positron emission tomography/computed tomography; PET/CT; EAP IST-00Ca

Interventions

MNPR-101-PCTA-177Lu BIOLOGICAL

MNPR-101-PCTA-177Lu is a monoclonal antibody-radionuclide conjugate intended to target and deliver radioactivity to solid tumors expressing uPAR.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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)