Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond t
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 researcher
| Condition(s) | Non-muscle Invasive Bladder Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: Cohorts A and B * 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 * In this context, adequate BCG therapy is defined as at least one of the following: * At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy * At least five of six dos |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
| Locations | Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States (+1 more sites) |
| Start date | 2021-11-08 |
| NCT ID | NCT05126472 |
| Official listing | https://clinicaltrials.gov/study/NCT05126472 |