LEGEND STUDY
Research type
Research Study
Full title
A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients Who Are BCG Naïve or Received Incomplete BCG Treatment
IRAS ID
1011150
Contact name
Michelle Darling
Contact email
Sponsor organisation
enGene Inc.
Clinicaltrials.gov Identifier
Research summary
This phase 1/2 study will evaluate the safety and tolerability of EG 70, a gene therapy, which is given inside the bladder. This study will measure its effectiveness on eliminating bladder tumors in patients with NMIBC who have failed or did not receive adequate Bacillus Calmette-Guérin (BCG) therapy and have been recommended to have their bladder removed. Patients who have received incomplete or have not received BCG therapy can also participate in the study. The standard of care for bladder cancer is the BCG therapy to prevent recurrence and/or progression (worsening of the cancer) in patients with high-grade NMIBC. Even with this treatment there can be failure of a complete response. In this study, all patients will receive a study drug, given into the lining of the bladder. This may cause an immune response inside the bladder and kill the cancer cells.
This study consists of 2 phases: Phase 1 (Dose escalation) of this study is already completed and confirmed the recommended Phase 2 Dose (RP2D) of 0.8mg/ml administered on a 4-dose regimen (weeks 1, 2, 5 and 6), based on safety and efficacy data. Phase 2 (Efficacy Expansion) will evaluate efficacy using the RP2D in 4 cohorts separately (BCG-unresponsive patients [Cohort 1], BCG-naïve or who have been exposed [Cohort 2A and 2B]) and BCG-unresponsive HG Ta/T1 papillary disease without CIS [Cohort 3]). Depending on patients disease status and current treatment plan, the study doctor will determine which Cohort patients will be assigned to.
Total duration for participation in this study can be upto 3 years, depending on how many cycles of treatment patients receive and how well patient respond to the treatment. Study duration may extend upto 148 weeks including Screening, 4 treatment cycles and Maintenance Treatment or Follow- Up Period.REC name
North East - York Research Ethics Committee
REC reference
25/NE/0025
Date of REC Opinion
25 Mar 2025
REC opinion
Further Information Favourable Opinion