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.
High-grade (HG) NMIBC (HG Ta, CIS, and/or T1) of urothelial histology that is unresponsive to adequate BCG therapy.
Stage, grade, and histology must be confirmed by the MSK Department of Pathology
Subjects with tumors of mixed urothelial/non-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; subjects with predominant or exclusively non-urothelial histology are excluded
In those subjects with CIS, the CIS must be present on the tumor sample from the most recent cystoscopy/TURBT
History of or currently being treated for muscle-invasive (T2, T3, T4) locally-advanced non-resectable or metastatic urothelial carcinoma.
Evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma.
Concurrent anti-cancer therapy, including investigational agents
Cohorts A and B Exceptions: Subjects on topical therapy (e.g. topical 5-
Memorial Sloan Kettering Cancer Center
Lead sponsor
Pin Down Bladder Cancer Research Foundation
Collaborator
Rockefeller University
Collaborator