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RECRUITING

NCT04752722

PHASE1/PHASE2

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

Sponsor: enGene, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2021-04-22

Completion Date

2028-11-30

Last Updated

2026-01-26

Healthy Volunteers

Conditions

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

Interventions

DRUG

EG-70 (phase 1)

Patients will receive up to four cycles of EG-70 administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes.One cycle lasts approximately 12 weeks and consists of either a 2-dose (Day 1 and Day 8) or 4-dose (Day 1, Day 8, Day 29 and Day 36) regimen.

DRUG

EG-70 (phase 2)

Patients will receive during Treatment Period, up to 4 cycles of EG-70 at the RP2D defined in Phase 1 administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes. One cycle lasts approximately 12 weeks. For Maintenance treatment 2 doses of EG-70 will be administered as a bladder instillation per 12-week cycle.

Inclusion Criteria: BCG-unresponsive Patients: 1. BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without coexisting papillary Ta/T1 tumors who are ineligible for or have elected not to undergo cystectomy, and have experienced CIS disease within 12 months of treatment where: adequate BCG regimen consists of at least 2 courses of BCG where the first course (induction) must have included at least 5 or 6 doses and the second course may have included a re-induction (at least 2 treatments) or maintenance (at least 2 doses), and Cis must be documented or indicated by pathology Phase 2 Only: 2. BCG-Naïve or BCG-incompletely treated Patients with CIS or BCG-unresponsive, HG Ta/T1 papillary disease without CIS: -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. All Patients: 3. Patients who have previously been treated with a checkpoint inhibitor and failed treatment are eligible for inclusion 30 days post-treatment (Phase 1) or 3 months post-treatment (Phase 2). 4. Male or non-pregnant, non-lactating female, 18 years or older. 5. Women of childbearing potential must have a negative pregnancy test at Screening. 6. Female patients of childbearing potential must be willing to consent to using highly effective birth control methods; Male patients are required to utilize a condom for the duration of the study treatment through 3 months post-dose. 7. In Phase 2, for patients with T1 lesions may be eligible after repeat TURBT if pathology shows non-invasive (Ta or less) or no disease. 8. Performance Status: Eastern Cooperative Oncology Group 0, 1, and 2. 9. Hematologic inclusion: a. Absolute neutrophil count \>1,500/mm3. b. Hemoglobin \>9.0 g/dL. c. Platelet count \>100,000/mm3. 10. Hepatic inclusion: a. Total bilirubin must be ≤1.5 x the upper limit of normal (ULN). b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤2.5 x ULN. 11. Adequate renal function with creatinine clearance \>30 mL/min 12. Prothrombin time and partial thromboplastin time ≤1.25 x ULN or within the therapeutic range if on anticoagulation therapy. 13. Must have satisfactory bladder function with ability to retain study drug for 60 minutes. Exclusion Criteria: 1. Active malignancies (i.e., progressing or requiring treatment change in the last 24 months). Exceptions allowed under Sponsor review. 2. Concurrent treatment with any chemotherapeutic agent. 3. History of partial cystectomy. 4. Treatment with last therapeutic agent (including intravesical chemotherapy post-TURBT) within 30 days of Screening (prior to the screening biopsy). 5. Patients who have received systemic immunosuppressive medication including high-dose corticosteroids. 6. History of severe asthma or other respiratory diseases. 7. History of unresolved vesicoureteral reflux or an indwelling urinary stent. 8. History of unresolved hydronephrosis due to ureteral obstruction. 9. Participation in any other research protocol involving administration of an investigational agent within 30 Days prior to screening or any prior treatment of NMIBC with any investigational gene or immunotherapy agent. 10. History of external beam radiation to the pelvis or prostate brachytherapy within the last 12 months. 11. History of interstitial lung disease and/or pneumonitis in patients who have previously received a PD-1 or PD-L1 inhibitor therapy. 12. Evidence of metastatic disease. 13. History of difficult catheterization that in the opinion of the Investigator will prevent administration of EG-70. 14. Active interstitial cystitis on cystoscopy or biopsy. 15. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 16. Known human immunodeficiency virus, Hepatitis B, or Hepatitis C infection. 17. Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months). 18. Hypersensitivity to any of the excipients of the study drug.

Locations (100)

The University of Alabama at Birmingham Clinical Research Unit (CRU)

Birmingham, Alabama, United States

Mayo Clinic

Scottsdale, Arizona, United States

Urological Associates of South Arizona

Tucson, Arizona, United States

Arkansas Urology

Little Rock, Arkansas, United States

University of California - Irvine Medical Center

Irvine, California, United States

UC San Diego Moores Cancer Center

La Jolla, 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

Colorado Clinical Research

Lakewood, Colorado, United States

The George Washington Medical Faculty Associates

Washington D.C., District of Columbia, United States

University of Florida

Jacksonville, Florida, United States

Sylvester Comprehensive Cancer Center / University of Miami Hospital and Clinics

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Urology of Indiana

Greenwood, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

John Hopkins Hospital

Baltimore, Maryland, United States

Chesapeake Urology Research Associates

Hanover, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, 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

Mayo Clinic

Rochester, Minnesota, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

New Jersey Urology, LLC

Voorhees Township, New Jersey, United States

Albany Medical College

Albany, New York, 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

Associated Medical Professionals of NY,

Syracuse, New York, United States

UNC Chapel Hill Hospital

Chapel Hill, North Carolina, United States

Duke Health - Duke Cancer Center

Durham, North Carolina, United States

Associated Urologists of North Carolina

Raleigh, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Central Ohio Urology Group

Gahanna, Ohio, United States

Clinical Research Solutions - Helios Clinical Research

Middleburg Heights, Ohio, United States

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States

Urology Associates, P.C.

Nashville, Tennessee, United States

Vanderbilt Univerity Medical Center

Nashville, Tennessee, United States

Urology Austin

Austin, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Houston Metro Urology

Houston, Texas, United States

Houston Methodist Hospital - Department of Urology

Houston, Texas, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States

Froedtert Hospital / Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Icon Cancer Center Windsor Gardens

Windsor Gardens, South Australia, Australia

Prostate Cancer Centre

Calgary, Alberta, Canada

Vancouver Prostate Centre

Vancouver, British Columbia, Canada

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

McGill University Health Center - Glen site

Montreal, Quebec, Canada

CHUM Centre Hospitalier de l Universite de Montreal

Montreal, Quebec, Canada

CHU d'Angers

Angers, France

CHU Bordeaux Pellegrin

Bordeaux, France

lnstitut Bergonie 229 Cour de l'Argonne

Bordeaux, France

CHU de Lille

Lille, France

Hospices Civils de Lyon

Lyon, France

Hopital Bichat Claude-Bernard

Paris, France

CHU de Rauen- Hopital Charles Nicolle

Rouen, France

Klinik fur Urologie, Uro-Onkologie, spezielle urologische und Roboter-assistierte Chirurgie Universitatsklinikum Koln (AOR)

Cologne, Germany

Urologicum Duisburg

Duisburg, Germany

Universitaetsklinikum Erlangen

Erlangen, Germany

Urologie Neandertal Mettmann

Mettmann, Germany

Studienpraxis Urologie

Nürtingen, Germany

Universitaetsklinikum Tubingen

Tübingen, Germany

Clinic Unit of Urology, IRCCS Ospedale San Raffaele

Milan, MI, Italy

Istituto Europeo di Oncologia

Milan, Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy

Fondazione Policlinico Universitario "A.Gemelli" IRCCS, Largo

Rome, Italy

Azienda Ospedaliero-Universitaria Sant'Andrea

Rome, Italy

UOC Urologia, IFO- lstituto Tumori "Regina Elena"

Rome, Italy

Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

The Catholic University of Korea, Soul St. Mary's Hospital

Seoul, South Korea

IOB - Hospital Quironsalud Barcelona

Barbera Del Valles, Spain

Fundacio Puigvert

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Germans Trias i Pujol

Barcelona, Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Quironsalud Madrid (Next Oncology)

Madrid, Spain

Hospital Universitario Infanta Sofia

Madrid, Spain

Hospital General Universitario Morales Meseguer

Murcia, Spain

Hospital Universitario Marqués de Valdecilla,

Santander, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Chi Mei Medical Center

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (100)