Cure My Disease

Don't miss your cure!

 Log in / Sign up

New bladder cancer drug shows promise in early trial

NCT ID NCT06637423

Disease control Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 4 times

Summary

This study tests a new drug called Sacituzumab Tirumotecan (Sac-TMT) for people with a type of bladder cancer that hasn't spread into the muscle. The drug is given directly into the bladder through a catheter. The main goals are to find the safest dose and see if people can tolerate it. About 32 participants with recurrent low-grade tumors will take part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 32 people

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

Started

Dec 2024

Expected to finish

Mar 2029

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: The key inclusion criteria include but are not limited to the following: * Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder * Must have visible tumor by cystoscopy within 12 weeks prior to first dose * Has intermediate-risk NMIBC defined as 1 or more of the following risk factors: * Multiple tumors * \>1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening * Early recurrence (\<1 year) of the initial diagnosis of low-grade disease * Solitary tumor \>3 cm * Failure of prior intravesical treatment * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder * Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC) * Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours) * Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and/or blepharitis, or severe corneal disease that prevents and/or delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Known additional malignancy that is progressing or has required active treatment within the past 3 years * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Intermediate risk non-muscle invasive bladder cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Non muscle invasive bladder cancer

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

    13 sites in 6 countries. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • CIUSSS de l'Estrie-CHUS ( Site 0002)

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Erasmus Medisch Centrum ( Site 0032)

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Gustave Roussy ( Site 0013)

    RECRUITING

    Villejuif, Val-de-Marne, 94805, France

  • HENRI MONDOR HOSPITAL ( Site 0011)

    RECRUITING

    Créteil, Val-de-Marne, 94010, France

  • Hospital Universitario 12 de Octubre ( Site 0042)

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen de la Victoria ( Site 0043)

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Hôpital Claude Huriez ( Site 0012)

    RECRUITING

    Lille, Nord, 59037, France

  • Johns Hopkins University ( Site 0055)

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Michael G Oefelein Clinical Trials ( Site 0053)

    RECRUITING

    Bakersfield, California, 93301, United States

  • Moffitt Cancer Center ( Site 0057)

    RECRUITING

    Tampa, Florida, 33612, United States

  • Northwestern University ( Site 0051)

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Princess Margaret Cancer Centre ( Site 0003)

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • St Bartholomew s Hospital ( Site 0061)

    RECRUITING

    London, London, City of, EC1A 7BE, United Kingdom

More trials for these conditions

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