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Looking for participantsPhase1/Phase2

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06637423

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sacituzumab tirumotecan (drug), Rescue medication (drug), Supportive care measures (drug)
How long the study runs
Study runs about 51 months (dates as stated)
About the drug or intervention
Sacituzumab tirumotecan — drug: Intravesical administration · Rescue medication — drug: Participants are allowed to take rescue medication for stomatitis or oral mucositis. · Supportive care measures — drug: Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
32
Started
2024-12-20
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for non-muscle invasive bladder cancer
  • • Phase1/Phase2 - 32 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-muscle invasive bladder cancer

Where?

  • • London - St Bartholomew s Hospital ( Site 0061)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Non-Muscle Invasive Bladder Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ visible tumor by cystoscopy within 12 weeks

What the study is looking for

  • ✓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

Who cannot take part

  • ✗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 that has spread...
  • ✗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...
See the full criteria
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.

Where Is This Study? (1 UK site)

St Bartholomew s Hospital ( Site 0061)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4407535510363

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10