Clinical Trial: NCT06337084
Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Monopar Therapeutics |
| Information Provided By: | Monopar Therapeutics |
| Last Update Posted: | 2026-09-03 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: MNPR-101-DFO*-89Zr
- Diagnostic Test: PET/CT Diagnostic Imaging
Other Study ID Numbers
- MNPR-101-D001
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | Monopar Therapeutics |
| Information Provided By: | Monopar Therapeutics |
| Last Update Posted: | 2026-09-03 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: MNPR-101-DFO*-89Zr
- Diagnostic Test: PET/CT Diagnostic Imaging
Other Study ID Numbers
- MNPR-101-D001