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LEGEND Study: EG-70 for Bladder Cancer

This study is testing a new treatment called EG-70 for non-muscle invasive bladder cancer (NMIBC) that has not responded to BCG treatment, or for high-risk NMIBC that was not fully treated with BCG, or for patients who haven't had BCG. EG-70 is given directly into the bladder. The study aims to see how safe EG-70 is and how well it shrinks bladder tumors. Success will be measured by how many patients have their tumors completely disappear. The study is currently enrolling about 350 participants who are 18 years or older. There's also a smaller part of the study looking at using a bladder rinse before EG-70.

Study design
This study has two phases: Phase 1 to find the best dose of EG-70, and Phase 2 to see how effective it is. It plans to enroll about 350 participants.
What's involved
You would receive EG-70 directly into your bladder via a catheter for up to four cycles, with each cycle lasting about 12 weeks. Some patients might receive a bladder rinse before EG-70.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for safety for approximately 2 to 3 years, and for tumor response for about 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04752722

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
enGene, Inc.
~350 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:EG-70 (phase 1)EG-70 (phase 2) Master ProtocolSurfactant Bladder Pre-Rinse and EG-70 (Substudy)

At a glance

Recruiting sites
100 of 102 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0.
Measured over Approximately 2 years
+2 more outcomes measured

Conditions

Superficial Bladder Cancer
Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
Non-muscle Invasive Bladder Cancer

Explore related trials

Carcinoma In SituNon-Muscle Invasive Bladder Carcinoma

NCT04752722

Where you'd take part

This study runs at 102 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Associated Urologists of North Carolina

    Raleigh, North Carolinastudy coordinator listed

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolinastudy coordinator listed

    Recruiting

  • Chesapeake Urology Research Associates

    Hanover, Marylandstudy coordinator listed

    Recruiting

  • Clinical Research Solutions - Helios Clinical Research

    Middleburg Heights, Ohiostudy coordinator listed

    Recruiting

  • Corewell Health Medical Group and Spectrum Health Hospitals

    Grand Rapids, Michiganstudy coordinator listed

    Recruiting

  • Emory University

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Froedtert Hospital / Medical College of Wisconsin

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Christine Tosone, Ms, RAC · STUDY_DIRECTOR · enGene, Inc.

Who to contact

enGene clinical trials
[email protected]
+18572991097
Email the study team

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Eligibility criteria

Inclusion

NMIBC with current Cis of the bladder, with or without coexisting papillary Ta/T1 NMIBC tumor(s), who are ineligible for or have elected not to undergo cystectomy, where: either: cohort 2a) no treatment with BCG but may have previously been treated with at least 1 dose of intravesical chemotherapy following transurethral resection of bladder tumor (TURBT) and Cis must be documented or cohort 2b) indicated by pathology incomplete BCG treatment (at least 1 dose and less than the 5+2 doses required for adequate dosing per Cohort 1) or cohort 3) patients who are BCG-unresponsive following adequate treatment, with HG Ta/T1 papillary disease without CIS.

What this trial measures

  • Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0.Approximately 2 years

    The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored.

  • Phase 2: Percentage of patients with cystoscopic CR at any time, based on exam, urine cytology and appropriate biopsies.Approximately 24 weeks

    Complete response rate will be measured by determining the number of patients without recurrence of disease.

  • Phase 2: Nature, incidence, relatedness, and severity of treatment emergent adverse events (as assessed by CTCAE v5.0)Approximately 3 years

    The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored.