Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06337084 | Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors | PHASE1 | RECRUITING | 12 | — | — | May 30, 2024 | Apr 1, 2026 | May 22, 2025 | 1 | Australia |
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...