Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06337084

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

Led by Monopar Therapeutics · Updated on 2025-05-22

12

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically and/or cytologically confirmed solid tumor cancer.
  • Age 18 years or older.
  • Measurable disease at least 1 cm on prior 18F-FDG PET/CT scan; up to 4 subjects allowed with FDG-avid disease not meeting 1 cm measurement on CT.
  • Ability to understand and willingness to sign a written informed consent document.
  • Prior standard-of-care 18F-FDG PET/CT scan within the past 60 days.
  • Tumor sample available for immunohistochemistry testing to show uPAR expression.
  • Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 before study drug administration if screening is more than 7 days prior.
  • Both males and females must agree to use highly effective contraception during dosing and up to 1 month after dosing.
  • Female patients who are breastfeeding must agree to stop breastfeeding before dosing and refrain from breastfeeding for 1 month after the last dose.
Not Eligible

You will not qualify if you...

  • Chemotherapy, radiotherapy (except short palliative radiotherapy), or immunotherapy within 14 days before MNPR-101-DFO*-89Zr administration, or ongoing adverse effects above grade 1 (excluding alopecia, anorexia, fatigue, neuropathy).
  • Prior treatment with radiopharmaceuticals or investigational agents within 4 weeks or 5 half-lives before first MNPR-101-DFO*-89Zr dose.
  • Evidence of impaired organ function before dosing, including:
    • Platelets less than 75 K/mcL or ANC less than 1.0 K/mcL.
    • Liver enzymes AST/ALT above 2.5 times normal limits or above 5 times for patients with liver metastases.
    • Bilirubin above 1.5 times normal limits or above 3 times for patients with Gilbert's Syndrome.
    • Renal function with eGFR less than 45 mL/min.
  • Other serious non-cancer diseases that may interfere with study objectives, safety, or compliance.
  • Cognitive impairment or contraindications affecting ability to consent or comply with study requirements.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Melbourne Theranostic Innovation Centre (MTIC)

North Melbourne, Victoria, Australia, 3051

Actively Recruiting

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Research Team

D

Director Clinical Operations

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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