Spots Global Cancer Trial Database for LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
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Trial Identification
Brief Title: LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
Official 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
Study ID: NCT04752722
Study Description
Brief 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.
Detailed Description: EG-70 is a novel non-viral gene therapy. EG-70 is designed to elicit a local immune response following delivery of the study gene therapy to the bladder urothelium. This approach of local administration through bladder instillation has the potential to induce a potent immune response exclusively at the site of the tumor, resulting in greater therapeutic benefit while reducing undesirable systemic toxicity. Eligible BCG-unresponsive NMIBC patients will be enrolled in Phase 1, and Cohort 1 of Phase 2. Eligible high-risk NMIBC patients who have been incompletely treated or are BCG-naïve will be enrolled starting in Phase 2 in a separate single-arm cohort (Cohort 2). Patients will be treated for up to four 12-week cycles of study drug instillation doses and assessments with follow up assessments.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Urological Associates of South Arizona, Tucson, Arizona, United States
University of California - Irvine Medical Center, Irvine, California, United States
Urology Group of Southern California / American Institute of Research, Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Tower Urology, Los Angeles, California, United States
Genesis Research, San Diego, California, United States
The George Washington Medical Faculty Associates, Washington, District of Columbia, United States
University of Florida, Jacksonville, Florida, United States
Emory University, Atlanta, Georgia, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Chesapeake Urology Research Associates, Hanover, Maryland, United States
Henry Ford Health System, Detroit, Michigan, United States
Corewell Health Medical Group and Spectrum Health Hospitals, Grand Rapids, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
New Jersey Urology, LLC, Voorhees, New Jersey, United States
Mount Sinai Medical Center, New Haven, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
UNC Chapel Hill Hospital, Chapel Hill, North Carolina, United States
Associated Urologists of North Carolina, Raleigh, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Clinical Research Solutions - Helios Clinical Research, Middleburg Heights, Ohio, United States
Oregon Health & Science University (OHSU), Portland, Oregon, United States
Carolina Urologic Research Center, LLC, Myrtle Beach, South Carolina, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Houston Methodist Hospital - Department of Urology, Houston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Froedtert Hospital / Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Christine Tosone, Ms, RAC
Affiliation: enGene, Inc.
Role: STUDY_DIRECTOR
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