Can a radioactive antibody light up hidden tumors on PET scans?

NCT ID NCT06337084

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers are testing an experimental imaging agent called MNPR-101-DFO*-89Zr in people with several types of solid tumors, including bladder, breast, lung, and pancreatic cancers. The agent combines an antibody with a radioactive label, which may help PET scans reveal where tumors are in the body. Participants receive one injection and then undergo three PET scans over about ten days. The study aims to see if the agent correctly shows all tumors and to check its safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MNPR-101-DFO*-89Zr, an experimental PET imaging agent made of an antibody plus a radioactive label
What this could lead to
If it works, this imaging agent could help doctors see tumors more clearly and predict which patients might benefit from certain therapies.
What could go wrong
This is a small early-stage pilot study, so the imaging agent may not reliably spot all tumors or prove safe in larger groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically and/or cytologically confirmed solid tumor cancer. 2. Age ≥18 years. 3. Measurable disease ≥ 1 cm on prior 18F-FDG PET/CT scan. Up to 4 subjects may be enrolled with FDG-avid disease which do not meet ≥ 1 cm measurement on CT. 4. Ability to understand and willingness to sign a written informed consent document. 5. A prior standard-of-care 18F-FDG PET/CT scan within past 60 days. 6. Tumor sample available for IHC testing to demonstrate uPAR expression. 7. Females of childbearing potential must have a negative serum pregnancy test at time of screening and a negative urine pregnancy test on Day 1 prior to study drug administration if screening is \>7 days prior to Day 1. A rapid serum pregnancy test result performed as standard-of-care will be accepted if available. 8. Both males and females must agree to use highly effective contraceptive precautions if conception is possible during the dosing period and up to 1 month after dosing. 9. Female patients who are lactating must agree to discontinue breastfeeding prior to the dose of study drug and must refrain from breastfeeding for 1 month following the last dose of study drug. Exclusion Criteria: 1. Chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), or immunotherapy within 14 days prior to administration of MNPR-101-DFO\*-89Zr, or continuing adverse effects (\>grade 1, excluding alopecia, anorexia, fatigue, and neuropathy) from such therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0). 2. Prior treatment with any radiopharmaceutical or investigational agents within 4 weeks or 5 effective half-lives, whichever is longer, prior to administration of the first dose of MNPR-101-DFO\*-89Zr. 3. Have evidence of impaired organ function at Screening and within 1 week prior to dosing MNPR-101-DFO\*-89Zr, particularly: * Bone marrow i. Platelets \<75 K/mcL. ii. ANC \<1.0 K/mcL. * Liver function i. AST/ALT \>2.5xULN (institutional upper limits of normal) OR \>5×ULN for patients with liver metastases. ii. Bilirubin \>1.5xULN OR \>3×ULN for patients with known Gilbert's Syndrome. * Renal function i. eGFR ≤45 mL/min determined using BSA-adjusted Chronic Kidney Disease Epidemiology Collaboration CKD-EPI 2021 formula \[https://www.kidney.org/professionals/kdoqi/gfr\_calculator\]. 4. Other serious, non-malignant diseases that may interfere (e.g., renal, hepatic, or hematologic) with the objectives of the study, safety, or compliance, as judged by the investigator. 5. Cognitive impairment or contraindications that may compromise the ability to give informed consent or comply with the requirements of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Melbourne Theranostic Innovation Centre (MTIC)

    North Melbourne, Victoria, 3051, Australia

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