Phase I Study of PLZ4-Coated Paclitaxel Micelle Therapy for Non-Muscle-Invasive Bladder Cancer After BCG Treatment

What this Trial Is About

Researchers are evaluating an investigational drug called PLZ4-coated paclitaxel-loaded nanoscale micelles PPM for treating non-muscle-invasive bladder cancer NMIBC that has not responded to previous BCG therapy. This Phase I trial aims to find the recommended dose of PPM for future studies, assess its side effects, and gather early information about its potential effectiveness. The study involves up to 29 patients with recurrent or resistant NMIBC after standard BCG treatment. PPM is a tiny particle containing the chemotherapy drug paclitaxel, designed to target bladder cancer cells specifically. In this trial, PPM will be administered directly into the bladder once a week for six weeks through a procedure called intravesical instillation. The trial includes a dose escalation stage with three dose levels of paclitaxel 25 mg, 50 mg, and 75 mg, followed by an expansion phase where up to 12 patients receive the 50 mg dose to evaluate effectiveness. Participants will undergo regular assessments including urine cytology and cystoscopy to monitor cancer response. Side effects will be tracked using a standard toxicity scale for up to six weeks after the last dose. Blood tests and molecular studies will be performed to check for systemic absorption and other effects. The total participation includes weekly treatments for six weeks with follow-up evaluations to monitor safety and preliminary outcomes.

A Phase I Intravesical PPM Therapy for NMIBC