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MNPR-101-DFO*-89Zr · 1 trial · 9 indications
The biodistribution of MNPR-101-DFO\*-89Zr is assessed via PET/CT imaging scans, particularly of target safety organs (e.g., liver, kidney, red marrow, and lungs). Dosimetry is calculated using OLINDA/EXM or a similar software.
Tumor SUV is measured via PET/CT imaging by calculating the amount of radiotracer uptake in identified tumors. SUV mean, max, and peak of the tumors will be summarized at each timepoint per subject. Tumor SUV will be analyzed between subjects with the same cancer type as well as between cancer types.
The safety profile of MNPR-101-DFO\*-89Zr will be determined through assessment of adverse event (AE) type, incidence, severity, time of appearance, and related causes (detected by physical explorations and laboratory tests). Adverse events will be graded and tabulated using NCI CTCAE v5.0.
| Arm | Type | Description |
|---|---|---|
| MNPR-101-DFO*-89Zr Single Infusion and PET/CT Imaging | EXPERIMENTAL | Participants receive a single injection of MNPR-101-DFO\*-89Zr on Day 1 with administered activity between 37-74 MBq (or 1-2 mCi). PET/CT imaging will occur post-infusion at 2 h (Day 1), once on Days 3-5, and once on Days 7-10. |
| Name | Type | Description |
|---|---|---|
| MNPR-101-DFO*-89Zr | DRUG | Participants will receive one dose of MNPR-101-DFO\*-89Zr infused intravenously on Day 1 for PET scans |
| PET/CT Diagnostic Imaging | DIAGNOSTIC_TEST | PET/CT imaging will occur post-infusion at 2 h (Day 1), once on Days 3-5, and once on Days 7-10 for tumor lesion observation. |
Inclusion Criteria: 1. Histologically and/or cytologically confirmed solid tumor cancer. 2. Age ≥18 years. 3. Measurable disease ≥ 1 cm on prior 18F-FDG PET/CT scan. Up to 4 subjects may be enrolled with FDG-avid disease which do not meet ≥ 1 cm measurement on CT. 4. Ability to understand and willi...
MNPR-101-DFO*-89Zr is an investigational diagnostic imaging agent being studied in adults with solid tumors, including bladder cancer, urothelial carcinoma, triple-negative breast cancer, lung cancer, colorectal cancer, gastric cancer, ovarian cancer, and pancreatic cancer. It is currently in Phase 1 clinical development.
MNPR-101-DFO*-89Zr targets uPAR, the urokinase plasminogen activator receptor. It is a small molecule designed for diagnostic imaging in oncology, and its targeting of uPAR is being evaluated in a Phase 1 clinical trial.
MNPR-101-DFO*-89Zr is being developed by Monopar Therapeutics Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol MNPR. The company is conducting a Phase 1 clinical trial of this diagnostic agent in patients with solid tumors.
MNPR-101-DFO*-89Zr is in Phase 1 clinical development. It is an investigational diagnostic agent and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants.
MNPR-101-DFO*-89Zr is being studied in one active Phase 1 clinical trial, NCT06337084, titled 'Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors.' The trial is enrolling 12 participants in Australia and is not yet recruiting.