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

Last updated: April 30, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Bladder Cancer

Urothelial Cancer

Treatment

Rescue medication

Supportive care measures

Sacituzumab tirumotecan

Clinical Study ID

NCT06637423
2870-027
2024-514983-23-00
U1111-1308-6998
2024-514983-23
MK-2870-027
  • Ages > 18
  • All Genders

Study Summary

The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.

Eligibility Criteria

Inclusion

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 thebladder

  • 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 atScreening

  • 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 assessedwithin 14 days prior to first dose

Exclusion

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 thebladder

  • Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasivebladder 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 cornealhealing

  • Has active inflammatory bowel disease requiring immunosuppressive medication orprevious history of inflammatory bowel disease (eg, Chron's disease, ulcerativecolitis, or chronic diarrhea)

  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease

  • Known additional malignancy that is progressing or has required active treatmentwithin the past 3 years

  • History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease.

Study Design

Total Participants: 32
Treatment Group(s): 3
Primary Treatment: Rescue medication
Phase: 1/2
Study Start date:
December 20, 2024
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • Princess Margaret Cancer Centre ( Site 0003)

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre ( Site 0003)

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

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

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

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

    Sherbrooke 6146143, Quebec 6115047 J1H 5N4
    Canada

    Site Not Available

  • Hôpital Claude Huriez ( Site 0012)

    Lille, Nord 59037
    France

    Active - Recruiting

  • Hôpital Claude Huriez ( Site 0012)

    Lille 2998324, Nord 59037
    France

    Site Not Available

  • HENRI MONDOR HOSPITAL ( Site 0011)

    Creteil, Val-de-Marne 94010
    France

    Site Not Available

  • HENRI MONDOR HOSPITAL ( Site 0011)

    Créteil, Val-de-Marne 94010
    France

    Active - Recruiting

  • HENRI MONDOR HOSPITAL ( Site 0011)

    Créteil 3022530, Val-de-Marne 94010
    France

    Site Not Available

  • Gustave Roussy ( Site 0013)

    Villejuif, Val-de-Marne 94805
    France

    Active - Recruiting

  • Gustave Roussy ( Site 0013)

    Villejuif 2968705, Val-de-Marne 94805
    France

    Site Not Available

  • Erasmus Medisch Centrum ( Site 0032)

    Rotterdam, South Holland 3015 GD
    Netherlands

    Active - Recruiting

  • Erasmus Medisch Centrum ( Site 0032)

    Rotterdam 2747891, South Holland 2743698 3015 GD
    Netherlands

    Site Not Available

  • Hospital Universitario Virgen de la Victoria ( Site 0043)

    Malaga, Andalucia 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria ( Site 0043)

    Málaga, Andalusia 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria ( Site 0043)

    Málaga 2514256, Andalusia 2593109 29010
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre ( Site 0042)

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre ( Site 0042)

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • St Bartholomew s Hospital ( Site 0061)

    London, London, City of EC1A 7BE
    United Kingdom

    Active - Recruiting

  • St Bartholomew s Hospital ( Site 0061)

    London 2643743, London, City of EC1A 7BE
    United Kingdom

    Site Not Available

  • Michael G Oefelein Clinical Trials ( Site 0053)

    Bakersfield, California 93301
    United States

    Active - Recruiting

  • Michael G Oefelein Clinical Trials ( Site 0053)

    Bakersfield 5325738, California 5332921 93301
    United States

    Site Not Available

  • Moffitt Cancer Center ( Site 0057)

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Moffitt Cancer Center ( Site 0057)

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Northwestern University ( Site 0051)

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern University ( Site 0051)

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Johns Hopkins University ( Site 0055)

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Johns Hopkins University ( Site 0055)

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.