RecruitingPhase 1NCT06337084

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

Open Label Pilot Study Evaluating Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors


Sponsor

Monopar Therapeutics

Enrollment

12 participants

Start Date

May 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new imaging agent called MNPR-101-DFO*-89Zr — a radioactive tracer that may help doctors better see solid tumors on PET scans by targeting a protein called uPAR found on cancer cells. **You may be eligible if...** - You are 18 or older - You have a confirmed solid tumor cancer - You have had a PET/CT scan in the past 60 days showing measurable disease - A tumor sample is available to test for uPAR protein expression - You are able to use effective contraception during and for 1 month after the study **You may NOT be eligible if...** - You received chemotherapy, radiation, or immunotherapy within the past 14 days - You received any radioactive drug or experimental treatment within the past 4 weeks - You have significantly impaired bone marrow, liver, or kidney function - You are pregnant or breastfeeding - You have other serious non-cancer diseases that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMNPR-101-DFO*-89Zr

Participants will receive one dose of MNPR-101-DFO\*-89Zr infused intravenously on Day 1 for PET scans

DIAGNOSTIC_TESTPET/CT Diagnostic Imaging

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.


Locations(1)

Melbourne Theranostic Innovation Centre (MTIC)

North Melbourne, Victoria, Australia

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NCT06337084


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