Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
Study NCT ID:
NCT06980506
Status:
AVAILABLE
Last Update Posted:
2025-05-22
First Post:
2025-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MNPR-101-DFO*-89Zr Expanded Access Program (EAP) for Patients With Solid Tumor Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-05-12', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}}, 'conditionsModule': {'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'], 'conditions': ['Cancer', 'Solid Tumor', 'Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* 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\n* Ability to understand and willingness to sign a written informed consent document\n\nKey Exclusion Criteria:\n\n* Continuing ≥ Grade 3 adverse reactions from prior systemic therapy (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0)\n* 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\n* Evidence of impaired organ function, particularly bone marrow, liver, kidney, or heart, according to specific test parameters\n* 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.'}, 'identificationModule': {'nctId': 'NCT06980506', 'briefTitle': 'MNPR-101-DFO*-89Zr Expanded Access Program (EAP) for Patients With Solid Tumor Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Monopar Therapeutics'}, 'officialTitle': 'Imaging of Patients With Solid Tumor Cancer Via Intermediate-Size Patient Population Expanded Access Investigational New Drug (IND)', 'orgStudyIdInfo': {'id': 'IST-00Ca'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MNPR-101-DFO*-89Zr', 'type': 'DIAGNOSTIC_TEST', 'description': 'MNPR-101-DFO\\*-89Zr is an antibody radionuclide conjugate intended to image solid tumors expressing uPAR.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77042', 'city': 'Houston', 'state': 'Texas', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'Excel Diagnostics & Nuclear Oncology Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Susan Cork, Therapy Coordinator', 'role': 'CONTACT', 'email': 'scork@exceldiagnostics.com', 'phone': '+1 713-781-6200', 'phoneExt': 'Ext. 3203'}, {'name': 'Nereyda Sauceda, Therapy Coordinator', 'role': 'CONTACT', 'email': 'nsauceda@exceldiagnostics.com', 'phone': '+1 713-781-6200', 'phoneExt': 'Ext. 3246'}], 'overallOfficials': [{'name': 'Ebrahim S. Delpassand, M.D. Chairman & Medical Director, Nuclear Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Excel Diagnostics & Nuclear Oncology Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monopar Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}