Clinical Trial

Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment, and who will not have the standard surgical procedure to remove the bladder. The researchers will test different doses of 2141-V11 to see which dose is safest in people. The researchers will also do tests to see how the body absorbs, distributes, and gets rid of 2141-V11. This study is one of the first to test 2141-V11 in people, and the first to test 2141-V11 delivered through a catheter into the bladder.
Protocol Amendment History 3 changes
critical Phase changed: Phase 1 -> Phase 1/2 2026-08-15
critical Primary endpoint(s) modified 2026-08-15
notable Enrollment increased: 55 -> 115 participants 2026-08-15
Trial Details
NCT Number NCT05126472
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Pin Down Bladder Cancer Research Foundation, Rockefeller University
Conditions Non-muscle Invasive Bladder Cancer
Enrollment 115 participants
Start Date 2021-11-08
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-14