A Phase 1b Clinical Study of Intravesical Photodynamic Therapy in Patients with Bacillus Calmette-Guerin-unresponsive Non-muscle-invasive Bladder Cancer.

ABSTRACT:

Background

A phase 1b study of photosensitizer TLD-1433-mediated photodynamic therapy (PDT) was performed in bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) patients.

Objective

The primary objectives were safety and tolerability of PDT, with secondary objectives of (1) pharmacokinetic (PK) properties of TLD-1433 and (2) efficacy, as evaluated by recurrence-free survival and complete response (CR) at 90 and 180 d for patients treated at the maximum recommended starting dose (0.35 mg/cm² bladder surface area) and the therapeutic dose (0.70 mg/cm²).

Design setting and participants

Six BCG-unresponsive patients were enrolled in an open-label, single-arm, dose-escalating study of PDT. TLD-1433 was instilled intra

SUBMITTER: Kulkarni GS 

PROVIDER: S-EPMC9257636 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature