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NCT04752722 · ClinicalTrials.gov record · last posted 2026-08-07

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

StatusRecruiting
PhasePhase 1/2
Started2021-04-22
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from the ClinicalTrials.gov record
This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with: NMIBC with CIS for whom BCG therapy is unresponsive, and other high risk patients with NMIBC. A Substudy will include a surfactant bladder rinse prior to the instillation of detalimogene in patients with NMIBC with CIS for whom BCG therapy is unresponsive.

Protocol amendment history 4 changes detected by DataLookout

2026-08-08
Primary completion pushed: 2026-06-30 → 2028-04-30
2026-08-08
Completion pushed: 2028-11-30 → 2030-10-30
2026-06-23
Primary endpoint(s) modified
WasPhase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0., Phase 2: Nature, incidence, relatedness, and severity of treatment emergent adverse events (as assessed by CTCAE v5.0), Phase 2: Percentage of patients with cystoscopic CR at 48 weeks, based on exam, urine cytology and appropriate biopsies.
NowPhase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0., Phase 2: Nature, incidence, relatedness, and severity of treatment emergent adverse events (as assessed by CTCAE v5.0), Phase 2: Percentage of patients with cystoscopic CR at any time, based on exam, urine cytology and appropriate biopsies.
2026-06-23
Trial arms changed: 2 → 3
Trial Details
NCT Number NCT04752722
Lead Sponsor enGene, Inc.
Conditions Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, Non-muscle Invasive Bladder Cancer
Enrollment 350 participants
Start Date 2021-04-22
Primary Completion 2028-04-30 (estimated)
Study Completion 2030-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-07