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New radioactive drug aims to destroy bladder tumors without surgery

NCT ID NCT07260162

Disease control Sponsor: Institut Cancerologie de l'Ouest 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called ATO-101 for a type of bladder cancer that hasn't responded to standard treatments. The drug delivers a short-range radioactive particle directly into the bladder to kill cancer cells while sparing healthy tissue. About 24 patients will receive the drug to find the safest dose and see if it 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
ATO-101 (a radioactive antibody that targets bladder cancer cells)
What this could lead to
If it works, this could offer a new treatment option for patients with bladder cancer that hasn't responded to standard therapy, potentially avoiding bladder removal.
What could go wrong
This is a very early (Phase 1) trial with only 24 participants, so it's too soon to know if it's safe or effective. The drug uses radiation, which could cause side effects.

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 24 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Performance Status (PS): 0 or 1. * Patient experiencing relapse following standard treatment (BCG therapy with or without Mitomycin), before radical surgery which is being considered as a therapeutic option. * Clinical evidence of NMIBC based on cystoscopy and proven histologically of papillary tumours. * Histologically confirmed bladder cancer patients relapsing without muscle invasion. * Negative serum/urine pregnancy test prior to ATO-101™ administration for female patient of childbearing potential. * Consent to use a contraception method for at least 3 months after administration of ATO-101™. * Adequate organ function confirmed by laboratory tests results allowing for safe administration of ATO-101™. Exclusion Criteria: * Patient with urinary incontinence. * Patient treated with anticoagulant or platelet antiaggregant therapies. * Symptoms of urine infection. * Patient with urethral stenosis. * Patient with valvular heart disease. * No history of congestive heart failure. * Known hypersensitivity to Girentuximab. * Exposure to any experimental diagnostic or therapeutic drug within 30 days prior the date of planned administration of ATO-101™. * Serious non-malignant disease that may interfere with the objectives of the study or with the safety or compliance of the patient as judged by the investigator. * Concomitant cancer in the past 5 years except cutaneous cancers (except melanoma) and in situ carcinoma in past 3 years. * Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), immunotherapy within 21 days of ATO-101™ administration. * Pregnant or likely to be pregnant or nursing patient.

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Bladder cancer

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Loire Atlantique, 44800, France

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Other studies related to the condition(s) this trial covers.