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Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started2024-05-30
View on ClinicalTrials.gov ↗
This is an open-label pilot study of a new PET/CT imaging agent MNPR-101-DFO\*-89Zr in patients with solid tumor cancers. These cancers may include bladder/urothelial, triple-negative breast, lung, colorectal, gastric, ovarian, and pancreatic cancers. MNPR-101-DFO\*-89Zr is made of MNPR-101, a humanized IgG1 monoclonal antibody and a radioisotope Zirconium-89. This imaging agent may show where tumors are present in the body using a PET-scan. Participants will be injected with the radioactive tracer once. After injection, participants will have 3 PET-scans. Each PET-scan will take about 30 minutes. The PET-scans are on separate days within 10 days after injection (e.g., 2 hours after injection, plus 3-5 days and 7-10 days after injection). Furthermore, the investigators will take blood samples 6 times (5 mL each). Blood pharmacokinetics (PK) will be measured on Day 1 at 10 min, 1h, 2h, once on Days 3-5, and once on Days 7-10. The study will see if the new imaging agent correctly shows all tumors. In the future, this method may be useful to help predict who will benefit from certain therapies.

Amendment history 3 changes detected by DataLookout

2026-09-04
notable
Enrollment closed, study ongoing
2026-09-04
critical
Primary completion pushed: 2026-04 → 2026-12
2026-09-04
minor
Completion pushed: 2026-04 → 2026-12
Trial Details
NCT Number NCT06337084
Lead Sponsor Monopar Therapeutics
Conditions Solid Tumor, Adult, Bladder Cancer, Urothelial Carcinoma, Triple-negative Breast Cancer, Lung Cancer, Colorectal Cancer, Gastric Cancer, Ovarian Cancer +1 more
Enrollment 12 participants
Start Date 2024-05-30
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-03