Can a radioactive drug seek out and attack solid tumors?

NCT ID NCT06617169

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

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.

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

Oct 2024

Expected to finish

Feb 2027

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. 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

  • Melbourne Theranostic Innovation Centre (MTIC)

    North Melbourne, Victoria, 3051, Australia

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