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Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients with Solid Tumors
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-04-10
Primary completion: 2025-04-01
Study completion finish: 2025-06-01
Study type
DIAGNOSTIC
Phase
PHASE1
Trial ID
NCT06337084
Intervention or treatment
DRUG: MNPR-101-DFO*-89Zr
DIAGNOSTIC_TEST: PET/CT Diagnostic Imaging
Conditions
- • Solid Tumor, Adult
- • Bladder Cancer
- • Urothelial Carcinoma
- • Triple-negative Breast Cancer
- • Lung Cancer
- • Colorectal Cancer
- • Gastric Cancer
- • Ovarian Cancer
- • Pancreatic Cancer
Find a site
Closest Location:
Melbourne Theranostic Innovation Centre (MTIC)
Research sites nearby
Select from list below to view details:
Melbourne Theranostic Innovation Centre (MTIC)
North Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: MNPR-101-DFO*-89Zr Single Infusion and PET/CT Imaging
| DRUG: MNPR-101-DFO*-89Zr
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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. | 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. | 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. | Screening through Day 30 Safety Visit. |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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. | Post infusion at 10 min, 1 h and 2 h on Day 1, once on Days 3-5, and once on Days 7-10. |
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