Pilot Study of MNPR-101-DFO*-89Zr Imaging to Detect and Measure Solid Tumors Using PETCT Scans in Adults

What this Trial Is About

Researchers are evaluating a new imaging agent called MNPR-101-DFO*-89Zr in patients with various solid tumor cancers, including bladder, triple-negative breast, lung, colorectal, gastric, ovarian, and pancreatic cancers. This open-label pilot study aims to assess how well this agent detects tumors using PETCT scans, its safety, and how it behaves in the body. The study is sponsored by Monopar Therapeutics and focuses on cancers that express the urokinase plasminogen activator receptor uPAR. Participants will receive a single intravenous injection of MNPR-101-DFO*-89Zr on Day 1 with a dose adjusted between 37 to 74 MBq and antibody mass dose increased stepwise to a maximum of 80 mg. After injection, three PETCT scans are performed about 2 hours post-infusion on Day 1, once between Days 3 to 5, and once between Days 7 to 10. Blood samples will be collected six times at specific intervals post-infusion to analyze pharmacokinetics. Dosimetry and tumor uptake values will be measured and compared to prior 18F-FDG PET scans. Participants will be monitored for adverse effects up to 30 days after infusion. The study includes safety assessments, measurement of tracer distribution in organs and tumors, and blood sample analysis. Each PET scan takes about 30 minutes, and the total involvement lasts approximately one month following the single infusion. Researchers will evaluate dosimetry, biodistribution, tumor uptake, and safety to understand the imaging agents potential for future clinical use.

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