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Radioactive 'Smart Bomb' targets Hard-to-Treat cancers in early trial

NCT ID NCT07020117

Disease control Sponsor: Aktis Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This early-phase trial is testing a new radioactive drug that seeks out a protein called Nectin-4 found on many cancer cells. The drug delivers a dose of radiation directly to the tumor, aiming to destroy it while sparing healthy tissue. About 150 adults with advanced bladder, breast, lung, cervical, colorectal, or head and neck cancers that have not responded to prior treatments will receive the drug. The main goals are to find the safest dose and to see if the drug can shrink tumors.

What this could mean

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

Active substance
[225Ac]Ac-AKY-1189 (a radioactive drug that targets Nectin-4 on cancer cells)
What this could lead to
If successful, this could lead to a new targeted radiation treatment for several types of advanced solid tumors that have stopped responding to other therapies.
What could go wrong
This is a very early (Phase 1b) and small study, so safety and effectiveness are not yet known. The radioactive drug may cause side effects, and it may not shrink tumors or improve survival.

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 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jun 2032

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: * Histologic or cytologic confirmation of locally advance or metastatic disease * Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1 * ECOG Performance Status of 0 or 1 * Adequate end-organ function * Ability to give informed consent and comply with study requirements * Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids * Documented disease progression on prior line of therapy for metastatic disease Exclusion Criteria: * Prior treatment with a therapeutic radiopharmaceutical * Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin * Received an investigational agent within the previous 28days * Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment * Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma cervical adenocarcinoma colorectal adenocarcinoma head and neck cancer Head and Neck Neoplasms hormone receptor-positive breast cancer non-small cell lung carcinoma triple-negative breast carcinoma urothelial carcinoma

As listed by the trial registrant

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

Cervical adenocarcinoma Colorectal adenocarcinoma Head and neck cancer Hormone receptor positive breast adenocarcinoma Non-small cell lung cancer Triple negative breast cancer (TNBC) Urothelial carcinoma bladder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advent Health Medical Group Radiation Oncology at Central Florida

    RECRUITING

    Orlando, Florida, 32804, United States

  • BAMF Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

    Contact Email: •••••@•••••

  • Biogenix Molecular, LLC

    RECRUITING

    Miami, Florida, 33165, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Irvine, California, 92618, United States

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine at Mt. Sinai

    RECRUITING

    New York, New York, 10029, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • United Theranostics

    RECRUITING

    Glen Burnie, Maryland, 21061, United States

    Contact Email: •••••@•••••

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas

    RECRUITING

    Westwood, Kansas, 66205, United States

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