Can a radioactive antibody light up hidden tumors on PET scans?
NCT ID NCT06337084
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Melbourne Theranostic Innovation Centre (MTIC)
North Melbourne, Victoria, 3051, Australia
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