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New treatment option for Non-Muscle Invasive Bladder Cancer
Official title A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
ClinicalTrials.gov ID: NCT06637423
What this study is testing
What is Sacituzumab tirumotecan?
Sacituzumab tirumotecan is an investigational medicine, being studied as a potential treatment for non-muscle invasive bladder cancer.
Also referred to as SKB264, sac-TMT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The key 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
You likely can't join if
- 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...
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease...
See the full eligibility criteria
- The key 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bakersfield, California, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Toronto, Ontario, Canada
- Sherbrooke, Quebec, Canada
- Lille, Nord, France
- Créteil, Val-de-Marne, France
- Villejuif, Val-de-Marne, France
- Rotterdam, South Holland, Netherlands
- Málaga, Andalusia, Spain
- Madrid, Spain
- London, London, City of, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bakersfield, California, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; Toronto, Ontario, Canada; Sherbrooke, Quebec, Canada and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.