Trials / Recruiting

RecruitingNCT06337084

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

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 12 (estimated)

Sponsor: Monopar Therapeutics · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DRUG	*MNPR-101-DFO-89Zr**	Participants will receive one dose of MNPR-101-DFO\*-89Zr infused intravenously on Day 1 for PET scans
DIAGNOSTIC_TEST	PET/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.

Timeline

Start date: 2024-05-30
Primary completion: 2026-04-01
Completion: 2026-04-01
First posted: 2024-03-29
Last updated: 2025-05-22

Locations

1 site across 1 country: Australia

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06337084. Inclusion in this directory is not an endorsement.