A Phase 1 interventional study of MNPR-101-DFO*-89Zr and PET/CT Diagnostic Imaging in Solid Tumor, Adult, Bladder Cancer and Urothelial Carcinoma, sponsored by Monopar Therapeutics. Active, not recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Monopar Therapeutics · Phase 1, Interventional, and Diagnostic
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.
This is an open-label, multi-center, imaging, and dosimetry pilot study to evaluate MNPR-101-DFO*-89Zr, a radiolabeled tracer composed of humanized IgG1 monoclonal antibody MNPR-101 which targets cancers that express the urokinase plasminogen activator receptor (uPAR) used with Positron Emission Tomography/Computed Tomography (PET/CT) imaging in patients with solid tumor cancers.
The study aims to determine the dosimetry and biodistribution, tumor standard uptake values (SUV), safety profile, and blood pharmacokinetics (PK) of MNPR-101-DFO*-89Zr.
On Day 1, patients will receive a single infusion of MNPR-101-DFO*-89Zr. All subjects will receive 37 to 74 MBq (1-2 mCi) of 89Zr with radioactivity determined based upon the site's PET/CT equipment. The antibody mass dose of MNPR-101-DFO*-89Zr will be increased in a stepwise fashion to a maximum of 80 mg. Before increasing to the next mass antibody dose level, each cohort of 2 patients will be assessed following the Day 7-10 visit for related hematologic or hepatologic events reported as CTCAE Grade 4, or CTCAE Grade 3 if lasting longer than 30 days.
PET/CT imaging will occur post-infusion at 2 h (Day 1), once on Days 3-5, and once on Days 7-10. PK blood sampling, for analysis via well or gamma counter, will occur post-infusion on Day 1 at 10 min, 1h, 2h, once on Days 3-5, and once on Days 7-10.
Dosimetry will be calculated using OLINDA/EXM or a similar software. Tumor SUVs will be assessed and compared to a prior 18F-FDG PET scan. PK measurements will be made via well or gamma counter and adjusted for radioactive decay.
The primary endpoints will assess dosimetry, biodistribution including target safety organs (e.g., liver, kidney, bone marrow, and lungs), tumor SUV, and the safety profile of MNPR-101-DFO*-89Zr. Patients will be followed for 1-month post infusion.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 12 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
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Exclusion Criteria:
Have evidence of impaired organ function at Screening and within 1 week prior to dosing MNPR-101-DFO*-89Zr, particularly:
ii. Bilirubin >1.5xULN OR >3×ULN for patients with known Gilbert's Syndrome.
Participants receive a single injection of MNPR-101-DFO\*-89Zr on Day 1 with administered activity between 37-74 MBq (or 1-2 mCi). PET/CT imaging will occur post-infusion at 2 h (Day 1), once on Days 3-5, and once on Days 7-10.
Drug: MNPR-101-DFO*-89Zr · Diagnostic Test: PET/CT Diagnostic Imaging
Participants will receive one dose of MNPR-101-DFO\*-89Zr infused intravenously on Day 1 for PET scans
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.
To assess dosimetry and biodistribution of MNPR-101-DFO*-89Zr
The biodistribution of MNPR-101-DFO\*-89Zr is assessed via PET/CT imaging scans, particularly of target safety organs (e.g., liver, kidney, red marrow, and lungs). Dosimetry is calculated using OLINDA/EXM or a similar software.
Time frame: Post infusion at 2 h on Day 1, once on Days 3-5, and once on Days 7-10.
To assess tumor Standard Uptake Value (SUV) of MNPR-101-DFO*-89Zr
Tumor SUV is measured via PET/CT imaging by calculating the amount of radiotracer uptake in identified tumors. SUV mean, max, and peak of the tumors will be summarized at each timepoint per subject. Tumor SUV will be analyzed between subjects with the same cancer type as well as between cancer types.
Time frame: Post infusion at 2 h on Day 1, once on Days 3-5, and once on Days 7-10.
To assess safety of MNPR-101-DFO*-89Zr as assessed by CTCAE 5.0
The safety profile of MNPR-101-DFO\*-89Zr will be determined through assessment of adverse event (AE) type, incidence, severity, time of appearance, and related causes (detected by physical explorations and laboratory tests). Adverse events will be graded and tabulated using NCI CTCAE v5.0.
Time frame: Screening through Day 30 Safety Visit.
To assess pharmacokinetics (PK) of MNPR-101-DFO*-89Zr via well or gamma counter
PK, mean and standard deviation plasma drug concentration are collected and measured via well or gamma counter to assess the imaging agent's interaction in blood and/or serum at each timepoint per subject.
Time frame: Post infusion at 10 min, 1 h and 2 h on Day 1, once on Days 3-5, and once on Days 7-10.
To assess tumor uptake to background and tumor uptake to liver ratios
Tumor to background (skeletal muscle) and tumor to liver uptake ratios using PET/CT imaging will be calculated from the lesion-free volume of interest (VOI) (reference tissue) using SUV\_mean\_lesion / SUV\_mean\_reference.
Time frame: Post infusion at 2 h on Day 1, once on Days 3-5, and once on Days 7-10.
To assess benefit of added cold MNPR-101 antibody
Determination of optimal cold antibody will be assessed based on the level of cold antibody where PK values in blood plateau and behave approximately linearly on a log scale over time, using time-corrected gamma counts of whole blood and/or serum.
Time frame: Post infusion at 10 min, 1 h and 2 h on Day 1, once on Days 3-5, and once on Days 7-10.
Plan to share: No
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