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LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
NCT04752722 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate the safety and efficacy of intravesical administration of 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 patients with NMIBC with Cis who are BCG-naïve or inadequately treated.
Conditions Studied
Interventions
- DRUG EG-70 (phase 1)
- DRUG EG-70 (phase 2)
Study Locations (20)
California
- University of California - Irvine Medical Center — Irvine
- UC San Diego Moores Cancer Center — La Jolla
- USC/Norris Comprehensive Cancer Center — Los Angeles
- Tower Urology — Los Angeles
- Genesis Research — San Diego
Arizona
- Mayo Clinic — Scottsdale
- Urological Associates of South Arizona — Tucson
Florida
- University of Florida — Jacksonville
- Sylvester Comprehensive Cancer Center / University of Miami Hospital and Clinics — Miami
Maryland
- John Hopkins Hospital — Baltimore
- Chesapeake Urology Research Associates — Hanover
Alabama
- The University of Alabama at Birmingham Clinical Research Unit (CRU) — Birmingham
Arkansas
- Arkansas Urology — Little Rock
Colorado
- Colorado Clinical Research — Lakewood
District of Columbia
- The George Washington Medical Faculty Associates — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2028-11-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04752722
The ClinicalTrials.gov registry entry for NCT04752722 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is enGene, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Non-muscle Invasive Bladder Cancer With Carcinoma in Situ appearing as the primary indexed condition, and to 2 interventions — of which EG-70 (phase 1) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04752722 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04752722 about?
NCT04752722 is a clinical study titled "LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve". This study will evaluate the safety and efficacy of intravesical administration of 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 Pha...
What is the current status of trial NCT04752722?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 350 participants. The study started on 2021-04-22. Estimated completion is 2028-11-30.
What conditions does trial NCT04752722 study?
This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, Superficial Bladder Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04752722?
The interventions under investigation include: EG-70 (phase 1) (DRUG), EG-70 (phase 2) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04752722?
This trial is sponsored by enGene, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04752722 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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