drugset / Trial / NCT06337084

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

NCT06337084 ↗

Phase 1 Recruiting 12 enrolled Monopar Therapeutics
NaSequentialOpen-labelDiagnostic

Summary

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.

Timeline

Start
2024-05-30
Primary completion
2026-04
Completion
2026-04

Drugs

EvaluationDrugModalityDoseRoute
Subject MNPR-101-DFO*-89Zr Monoclonal antibody 37 mbq Intravenous
Subject MNPR-101-DFO*-89Zr Monoclonal antibody 74 mbq Intravenous
Subject MNPR-101-DFO*-89Zr Monoclonal antibody 80 mg Intravenous