A Phase I Study of 2141-V11 Immunotherapy in People with Non-Muscle Invasive Bladder Cancer that Did Not Respond to Standard Treatment

Full Title

Phase I/II Study Evaluating the Safety and Tolerability of a Locally Administered Anti-CD40 Agonist Antibody (2141-V11) in Subjects with Bladder Cancer

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy 2141-V11 that can be given safely in people with bladder cancer that has not invaded the bladder muscle wall, has come back after BCG therapy, and will not be surgically removed. The drug 2141-V11 attaches to a protein on immune cells and activates the immune system to find and kill bladder cancer cells. It is given directly into the bladder through a catheter (flexible tube).

Protocol
21-314
Phase
Phase I/II (phases 1 and 2 combined)
Disease Status
Newly Diagnosed & Relapsed/Refractory
Investigator
ClinicalTrials.gov ID
NCT05126472