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Radioactive 'Smart Bomb' targets Hard-to-Treat cancers in first human test

NCT ID NCT06147037

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug that delivers a tiny amount of radiation directly to cancer cells. It is for people with advanced solid tumors (like lung, colon, or pancreatic cancer) that have not responded to standard treatments. The study will check if the drug is safe, how it spreads in the body, and what dose might work best.

What this could mean

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

Active substance
a radioactive drug (actinium-225 attached to a targeting antibody) that delivers radiation directly to cancer cells
What this could lead to
If it works, this could offer a new treatment option for people with advanced solid tumors that have stopped responding to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 70 participants, so safety and the right dose are still being figured out. The radioactive drug may cause side effects and may not shrink tumors.

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

13 people

The number who actually took part.

Started

Jul 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 to 130 years

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.

Key Inclusion Criteria: Histologically and/or cytologically confirmed solid tumor that is metastatic, locally advanced, recurrent or inoperable. Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the participant refuses standard therapy. Measurable disease as defined by RECIST Version 1.1 ECOG Performance status of 0 or 1 Adequate organ function Key Exclusion Criteria: Previous treatment with any systemic radiopharmaceutical Prior anti-cancer therapy unless adequate washout and recovery from toxicities Contraindications to or inability to perform the imaging procedures required in this study Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2107 Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month) Patients with known CNS metastatic disease unless treated and stable

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Conditions

The condition(s) this trial relates to.

colorectal carcinoma colorectal neoplasm gastric cancer gastric neoplasm head and neck squamous cell carcinoma neoplasm non-small cell lung carcinoma pancreatic ductal adenocarcinoma renal cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Advanced solid tumor Gastric cancer Head and neck squamous cell carcinoma Metastatic colorectal carcinoma Non-small cell lung cancer Pancreatic ductal adenocarcinoma Renal cell carcinoma

Contacts and locations

Locations

  • Research Site

    Palo Alto, California, 94304, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Omaha, Nebraska, 68130, United States

  • Research Site

    Cleveland, Ohio, 44195, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Seattle, Washington, 98109, United States

  • Research Site

    Montreal, Quebec, H2X 0A9, Canada

  • Research Site

    Sherbrooke, Quebec, J1H 5N4, Canada

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