A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027) (NCT06637423) | Clinical Trial Compass
RecruitingPhase 1/2
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
United States, Canada32 participantsStarted 2024-12-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 chroni…
What they're measuring
1
Number of Participants with Dose Limiting Toxicity (DLT)
Timeframe: Up to approximately 7 weeks
2
Number of Participants Experiencing an Adverse Event (AE)
Timeframe: Up to approximately 10 weeks
3
Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)