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Radioactive 'Smart Bomb' for tumours tested in early trial

NCT ID NCT03746431

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a radioactive drug designed to seek out and destroy cancer cells in people with advanced solid tumours that had stopped responding to other treatments. The drug targets a protein called IGF-1R found on many cancer cells. The study aimed to find a safe dose and check for side effects, but it was terminated before completion.

What this could mean

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

Active substance
Radioactive antibody (225Ac-FPI-1434) targeting IGF-1R
What this could lead to
If successful, this could point toward a new treatment option for patients with advanced solid tumours that have not responded to standard therapies.
What could go wrong
This was an early phase 1 trial, so safety and dosing were still being figured out. The trial was terminated, meaning it did not continue as planned, and results may not be available.

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

78 people

The number who actually took part.

Started

Jan 2019

Finished

Dec 2025

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. Pathologically documented, definitively diagnosed, advanced solid tumour that is refractory to all standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy. 2. Measurable or evaluable disease in accordance with RECIST 1.1. 3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1. 4. Life expectancy of greater than 3 months as judged by the treating physician. 5. Available tumour tissue (either archival or fresh biopsy) for IGF-1R immunohistochemistry. Submission of the tissue is not required prior to enrollment. 6. Adequate heart, kidney, and liver function 7. Adequate bone marrow reserves 8. Ability to understand and the willingness to sign a written informed consent document. Phase 2 Specific 9. Histologically and/or cytologically documented diagnosis of locally advanced, inoperable, metastatic, or recurrent solid tumour types: endometrial, cervical, ovarian, TNBC, HER 2-negative breast, HNSCC, ACC, or uveal melanoma. 10. Have measurable disease per RECIST 1.1 Failure to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist or is not tolerable. Imaging Eligibility 11. Prior to the initial \[225Ac\]-FPI-1434 cycle: Sufficient target expression in at least 1 lesion following \[111In\]-FPI-1547 and SPECT imaging. Exclusion Criteria: 1. Systemic therapeutic radiopharmaceutical within 6 months prior to enrollment into this study. 2. Contraindications to or inability to perform the required imaging procedures in this study (e.g., inability to lay flat during scan time) 3. Uncontrolled brain metastasis, including but not limited to the need for treatment with steroids, surgery or radiation therapy. 4. Anticancer therapy (including investigational agents) or external beam radiation therapy within 14 days of the dosing of \[111In\]-FPI-1547 5. Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast cancer, cervical cancer, prostate) that have undergone potentially curative therapy are not excluded. 6. Residual CTCAE ≥ Grade 2 side effects of prior therapy, with the exception of residual grade 2 alopecia. 7. Prior organ transplantation, including stem cell transplantation. 8. Any prior treatment with nitrosoureas or actinomycin-D. 9. Clinically relevant levels of protein in the urine 10. Known or suspected allergies or contraindications to the Investigational Products or any component of the investigational drug formulation. 11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. 12. Received \> 20 Gy prior radiation to large areas of the bone marrow

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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

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Centre Hospitalier De I'Universite de Montreal

    Montreal, Quebec, H2X 0C1, Canada

  • City of Hope

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Juravinski Cancer Center - Hamilton Health

    Hamilton, Ontario, L8V 5C2, Canada

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C1, Canada

  • Quebec University Hospital- Laval

    Québec, Quebec, G1R 2J6, Canada

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14203, United States

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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