Can a radioactive drug seek out and attack solid tumors?
NCT ID NCT06617169
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This early trial tests a radioactive drug called MNPR-101-PCTA-177Lu in adults with advanced solid tumors, including bladder, breast, lung, and pancreatic cancers. Participants receive three equal doses by IV over two 12-week cycles. The main goal is to find a safe dose and understand side effects, while also checking whether the drug shrinks tumors.
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-PCTA-177Lu, a radioactive drug given intravenously that targets cancer cells
- What this could lead to
- If it works, this could lead to a new treatment option for several hard-to-treat solid tumors, including bladder, breast, lung, and pancreatic cancers.
- What could go wrong
- This is an early, small phase 1 trial focused on safety, so it may not show clear benefit. The radioactive drug can cause side effects, and the right dose is still being determined.
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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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Oct 2024
- Expected to finish
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Feb 2027
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. Participated in the MNPR-101-D001 study. 2. 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. 3. Both males and females must agree to use highly effective contraceptive precautions if conception is possible during the dosing period and up to 3 months after dosing. 4. Female patients who are lactating must agree to discontinue breastfeeding prior to the dose of study drug and must refrain from breastfeeding for 3 months 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-PCTA-177Lu. 2. Continuing ≥ Grade 3 adverse reactions from prior systemic therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0). 3. Prior treatment with any radiopharmaceutical or investigational agents within 4 weeks or 5 half-lives, whichever is longer, prior to administration of the first dose of MNPR-101-PCTA-177Lu other than MNPR-101-DFO\*-89Zr. 4. Have evidence of impaired organ function at Screening and prior to dosing, particularly: • Bone marrow: i. Platelets ≤150×10\^9/L. ii. Absolute neutrophil count ≤1.5×10\^9/L. iii. Hemoglobin \<9g/dL (no red blood cell transfusion in the previous 4 weeks). • Liver function: i. AST/ALT \>3xULN (institutional upper limits of normal) OR \>5×ULN for patients with liver metastases. ii. Bilirubin \>1.5xULN OR \>3xULN 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 \[https://www.kidney.org/professionals/kdoqi/gfr\_calculator\]. 5. Safety event of significance in MNPR-101-D001 study: 1. a related CTCAE Grade 4 hematologic or hepatologic event 2. a related CTCAE Grade 3 hematologic or hepatologic event which lasted \>30 days 6. Unacceptable value for projected organ dose based upon dosimetry from the MNPR-101-D001 study that exceeds safe absorbed dose limits, as determined by Monopar. 7. Other serious, non-malignant diseases (e.g., renal, hepatic, or hematologic) that may interfere with objectives of the study, safety, or compliance, as judged by the investigator. 8. Cognitive impairment or contraindications that may compromise ability to give informed consent or comply with 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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