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Study of Sacituzumab Tirumotecan for Bladder Cancer

This study is testing a drug called Sacituzumab Tirumotecan, given directly into the bladder, for people with non-muscle invasive bladder cancer (NMIBC). Researchers want to find out how safe Sacituzumab Tirumotecan is and how well people can tolerate it. They will also determine the highest dose that can be given without causing too many problems. This information will help them decide on a dose for future studies to see how effective the drug is. You may be able to join if you are 18 or older, have recurrent low-grade NMIBC, and have visible tumors. The study aims to enroll 32 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is designed to find the safest and most tolerable dose of Sacituzumab Tirumotecan.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for dose-limiting toxicity for up to approximately 7 weeks, for adverse events for up to approximately 10 weeks, and for discontinuing treatment due to adverse events for up to approximately 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06637423

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~32 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecanRescue medicationSupportive care measures

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose Limiting Toxicity (DLT)
Measured over Up to approximately 7 weeks
+2 more outcomes measured

Conditions

Non-Muscle Invasive Bladder Cancer

Explore related trials

Bladder Carcinoma

NCT06637423

Where you'd take part

This study runs at 13 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

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

    Sherbrooke, Quebec, Canadastudy coordinator listed

    Recruiting

  • Erasmus Medisch Centrum ( Site 0032)

    Rotterdam, South Holland, Netherlandsstudy coordinator listed

    Recruiting

  • Gustave Roussy ( Site 0013)

    Villejuif, Val-de-Marne, Francestudy coordinator listed

    Recruiting

  • HENRI MONDOR HOSPITAL ( Site 0011)

    Créteil, Val-de-Marne, Francestudy coordinator listed

    Recruiting

  • Hôpital Claude Huriez ( Site 0012)

    Lille, Nord, Francestudy coordinator listed

    Recruiting

  • Hospital Universitario 12 de Octubre ( Site 0042)

    Madrid, Spainstudy coordinator listed

    Recruiting

  • Hospital Universitario Virgen de la Victoria ( Site 0043)

    Málaga, Andalusia, Spainstudy coordinator listed

    Recruiting

  • Johns Hopkins University ( Site 0055)

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Dose Limiting Toxicity (DLT)Up to approximately 7 weeks

    DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (7 weeks). All toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0.

  • Number of Participants Experiencing an Adverse Event (AE)Up to approximately 10 weeks

    An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who experience an AE will be reported.

  • Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)Up to approximately 6 weeks

    An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who discontinue study treatment due to an AE will be reported.