A Phase I trial of PLZ4-coated paclitaxel-loaded micelles in patients with refractory non–muscle-invasive bladder cancer

NCT06173349. While most bladder cancers do not invade into the muscle layer of the bladder (called non–muscle-invasive bladder cancer or NMIBC), recurrences are common despite treatments administered directly to the bladder and can ultimately require removal of the entire bladder (radical cystectomy), a surgical procedure that adversely impacts quality of life and poses significant risks. As a result, there is an urgent need for additional effective treatments that can prevent recurrences and preserve the bladder.This study is testing a new system of delivering chemotherapy directly into the bladder. This targeted nanoparticle system contains paclitaxel, a chemotherapy drug, packaged inside very small particles (called micelles) coated with peptides designed to attach specifically to bladder cancer cells. This targeting may help concentrate the drug in cancer cells while reducing toxicity to normal bladder cells.We describe this early-phase clinical trial, in which a small group of patients with resistant NMIBC will receive this treatment once a week for 6 weeks. The main goal is to evaluate safety and side effects, but the study will also involve monitoring for response to treatment and how long patients remain cancer free.This research aims to explore whether this targeted drug delivery approach could become a safer, bladder-preserving treatment option for patients with difficult-to-treat NMIBC.