This study is looking at a new drug called 2141-V11 for people with non-muscle invasive bladder cancer that has not responded to standard treatments. The main goal is to test how safe 2141-V11 is when given in different doses. Participants will receive this treatment through a catheter placed in the bladder. This is one of the first times 2141-V11 is being tested in people.
The trial ID is NCT05126472. This is a Phase 1 study, which means it is looking at how safe the treatment is and how well it works. It is regulated by the FDA and hopes to enroll about 55 participants.
Who can join
Adults aged 18 and older can join this study. It's open to both men and women with specific types of bladder cancer that didn't respond to previous treatments. Some people who have had certain surgeries or health issues may not be able to join. The team will check if each person is eligible to participate.
Condition
Non-muscle Invasive Bladder Cancer
Age group
Adult, Older adult
Sex
All sexes
The study team makes the final call on eligibility.
What happens in the study
Participants will be grouped into different cohorts. Cohort A will receive 2141-V11 through the bladder once a week for three weeks. Cohort B will get a fixed dose of 10 mg every three weeks for four doses. Cohort C will receive a single dose of 10 mg during a standard examination before planned surgery. Everyone will be monitored for their response to the treatment.
Where
This trial is enrolling at 7 locations. Recruiting sites are listed first.
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey
Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey
Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York
Recruiting
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York
Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey
Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York
Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Medical OncologistMedical Oncologist · New York, NY · New York · NY
Directs translational prostate cancer research, MSK. Treats prostate cancer, bladder cancer, testicular cancer and penile cancer. Works as a genitourinary medical oncologist. Based in New York. Also treats kidney cancer. Chosen on merit.
Medical OncologistMedical Oncologist · New York, NY · New York · NY
Led global trials in liver and bile duct cancer. Treats pancreatic cancer, gallbladder cancer, bile duct cancer and liver cancer. Offers targeted therapy. Works as a gastrointestinal medical oncologist. Based in New York. Chosen on merit.
Medical OncologistMedical Oncologist · Salt Lake City, UT · Utah · UT
Directs genitourinary oncology at Huntsman Cancer Institute. Treats pancreatic cancer, liver cancer, gallbladder cancer and esophageal cancer. Based in Salt Lake City, Utah. Also treats stomach cancer and colorectal cancer. Chosen on merit.