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NCT04752722 · ClinicalTrials.gov registry record · Phase 1
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
A Phase 1 study of Non-muscle Invasive Bladder Cancer With Carcinoma in Situ and Superficial Bladder Cancer, sponsored by enGene.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT04752722 is a Phase 1 study of Non-muscle Invasive Bladder Cancer With Carcinoma in Situ and Superficial Bladder Cancer that is actively recruiting participants, run by enGene. The registered enrollment target is 350 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT04752722, a Phase 1 study of Non-muscle Invasive Bladder Cancer With Carcinoma in Situ and Superficial Bladder Cancer, is actively recruiting participants, sponsored by enGene.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. 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.
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.
NCT04752722 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Arizona, Florida.
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.
What interventions are being tested in trial NCT04752722?
The interventions under investigation include: EG-70 (phase 1) (DRUG), EG-70 (phase 2) (DRUG).
Who is sponsoring clinical trial NCT04752722?
This trial is sponsored by enGene, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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