A Phase 12 Study of EG-70 Gene Therapy Delivered into the Bladder for Patients With BCG-Unresponsive and High-Risk Non-Muscle Invasive Bladder Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intravesical administration of detalimogene EG-70, a novel non-viral gene therapy, in patients with non-muscle invasive bladder cancer NMIBC. The study focuses on patients with carcinoma in situ CIS unresponsive to BCG therapy and other high-risk NMIBC patients, including those who are BCG-nafve or incompletely treated. The trial includes a Phase 1 dose-escalation to determine safety and recommended dose, followed by a Phase 2 to assess treatment effectiveness. Participants will receive EG-70 via bladder instillation with a catheter in cycles lasting about 12 weeks. Phase 1 involves up to four cycles with either two or four doses per cycle, aiming for a 60-minute retention time. Phase 2 participants receive four instillations per cycle for up to four cycles at the recommended dose. Those achieving complete response may continue with maintenance treatment involving two doses per 12-week cycle. A substudy includes a surfactant bladder rinse before EG-70 instillation, with a shortened administration time. During the study, participants undergo regular assessments including cystoscopy, urine cytology, and biopsies to monitor response and safety. Researchers track adverse events, treatment response rates, duration of response, progression-free survival, and quality of life over periods ranging from weeks to years. Safety monitoring follows standardized criteria, and participants may continue in maintenance cycles if responding. The total study duration extends up to approximately nine years from start to completion.

LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve