Phase I Study Evaluating the Safety and Tolerability of Locally Administered Anti-CD40 Agonist Antibody (2141-V11) in Subjects With Bladder Cancer
Memorial Sloan Kettering Cancer Center
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.
Description
If during Period 1 treatment, the treating physician notices recurrent disease in the bladder, the patient should undergo a biopsy or TURBT. If the pathology returns as HG Ta or CIS, the patient can resume treatment. If pathology returns as HG T1, the patient will be removed from treatment. If a high-grade recurrence occurs during period 2 or 3 treatments, the patient will be removed from treatment.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, adequa…