MedTrace Logo

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

NCT06337084 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Monopar Therapeutics

    lead INDUSTRY

Principal Investigators

  • Prof. Rod Hicks, MD · Melbourne Theranostic Innovation Centre (MTIC)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06337084 on ClinicalTrials.gov