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Trial Title:
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
NCT ID:
NCT06637423
Condition:
Non-Muscle Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
Non-Muscle Invasive Bladder Cancer
Low Grade
Intermediate Risk
Recurrent Low-Grade
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sacituzumab tirumotecan
Description:
Intravesical administration
Arm group label:
Sacituzumab tirumotecan
Other name:
SKB264
Other name:
sac-TMT
Other name:
MK-2870
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.
Criteria for eligibility:
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)
- Locally documented history of histologically confirmed low-grade Ta NMIBC
- 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 nonmuscle invasive bladder cancer (Ta NMIBC)
- Has active total bladder incontinence, active urinary tract infection (UTI),
neurogenic bladder, or urethral stricture
- Past or current history of high-grade (Ta or T1or CIS) NMIBC, muscle invasive
bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 26, 2024
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06637423
https://www.merckclinicaltrials.com/
