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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (1 UK site)
St Bartholomew s Hospital ( Site 0061)
London EC1A 7BE, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
