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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

April 22, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

November 30, 2028

Conditions
Superficial Bladder CancerNon-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.

Trial Locations (100)

100

RECRUITING

National Taiwan University Hospital, Taipei

807

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

2076

RECRUITING

Sydney Adventist Hospital, Wahroonga

4215

RECRUITING

Gold Coast University Hospital, Southport

5087

RECRUITING

Icon Cancer Center Windsor Gardens, Windsor Gardens

10016

COMPLETED

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York

10029

RECRUITING

Mount Sinai Medical Center, New Haven

12208

RECRUITING

Albany Medical College, Albany

13210

RECRUITING

Associated Medical Professionals of NY,, Syracuse

13620

RECRUITING

Seoul National University Bundang Hospital, Seongnam

20037

RECRUITING

The George Washington Medical Faculty Associates, Washington D.C.

20132

RECRUITING

Clinic Unit of Urology, IRCCS Ospedale San Raffaele, Milan

20141

RECRUITING

Istituto Europeo di Oncologia, Milan

21076

RECRUITING

Chesapeake Urology Research Associates, Hanover

21287

RECRUITING

John Hopkins Hospital, Baltimore

22903

RECRUITING

University of Virginia Comprehensive Cancer Center, Charlottesville

27514

RECRUITING

UNC Chapel Hill Hospital, Chapel Hill

27612

RECRUITING

Associated Urologists of North Carolina, Raleigh

28007

RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

28223

RECRUITING

Hospital Quironsalud Madrid (Next Oncology), Madrid

28702

RECRUITING

Hospital Universitario Infanta Sofia, Madrid

29572

RECRUITING

Carolina Urologic Research Center, LLC, Myrtle Beach

30008

RECRUITING

Hospital General Universitario Morales Meseguer, Murcia

30322

RECRUITING

Emory University, Atlanta

32209

RECRUITING

University of Florida, Jacksonville

33076

RECRUITING

CHU Bordeaux Pellegrin, Bordeaux

RECRUITING

lnstitut Bergonie 229 Cour de l'Argonne, Bordeaux

33136

RECRUITING

Sylvester Comprehensive Cancer Center / University of Miami Hospital and Clinics, Miami

35249

RECRUITING

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

37209

RECRUITING

Urology Associates, P.C., Nashville

37232

RECRUITING

Vanderbilt Univerity Medical Center, Nashville

39008

RECRUITING

Hospital Universitario Marqués de Valdecilla,, Santander

40447

RECRUITING

China Medical University Hospital, Taichung

40705

RECRUITING

Taichung Veterans General Hospital, Taichung

40822

RECRUITING

Urologie Neandertal Mettmann, Mettmann

43230

RECRUITING

Central Ohio Urology Group, Gahanna

43614

RECRUITING

The University of Toledo Medical Center, Toledo

44130

RECRUITING

Clinical Research Solutions - Helios Clinical Research, Middleburg Heights

45219

RECRUITING

University of Cincinnati Medical Center, Cincinnati

45227

RECRUITING

Brigham and Women's Hospital, Boston

46143

RECRUITING

Urology of Indiana, Greenwood

47169

RECRUITING

Urologicum Duisburg, Duisburg

48201

RECRUITING

Karmanos Cancer Institute, Detroit

48202

RECRUITING

Henry Ford Health System, Detroit

49503

RECRUITING

Corewell Health Medical Group and Spectrum Health Hospitals, Grand Rapids

49933

RECRUITING

CHU d'Angers, Angers

50937

RECRUITING

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

52336

RECRUITING

Froedtert Hospital / Medical College of Wisconsin, Milwaukee

55455

RECRUITING

University of Minnesota, Minneapolis

55905

RECRUITING

Mayo Clinic, Rochester

58128

RECRUITING

Chonnam National University Hwasun Hospital, Hwasun

59000

RECRUITING

CHU de Lille, Lille

60607

RECRUITING

Rush University Medical Center, Chicago

66160

RECRUITING

University of Kansas Medical Center, Kansas City

69002

RECRUITING

Hospices Civils de Lyon, Lyon

71004

RECRUITING

Chi Mei Medical Center, Tainan City

72076

RECRUITING

Universitaetsklinikum Tubingen, Tübingen

72211

RECRUITING

Arkansas Urology, Little Rock

72622

RECRUITING

Studienpraxis Urologie, Nürtingen

75018

RECRUITING

Hopital Bichat Claude-Bernard, Paris

75390

RECRUITING

UT Southwestern Medical Center, Dallas

76031

RECRUITING

CHU de Rauen- Hopital Charles Nicolle, Rouen

77027

RECRUITING

Houston Metro Urology, Houston

77030

RECRUITING

Houston Methodist Hospital - Department of Urology, Houston

RECRUITING

University of Texas - MD Anderson Cancer Center, Houston

78745

RECRUITING

Urology Austin, Austin

80131

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli

80228

RECRUITING

Colorado Clinical Research, Lakewood

84112

RECRUITING

Huntsman Cancer Institute, University of Utah, Salt Lake City

85259

RECRUITING

Mayo Clinic, Scottsdale

85715

RECRUITING

Urological Associates of South Arizona, Tucson

90017

WITHDRAWN

Urology Group of Southern California / American Institute of Research, Los Angeles

90033

RECRUITING

USC/Norris Comprehensive Cancer Center, Los Angeles

90048

RECRUITING

Tower Urology, Los Angeles

92037

RECRUITING

UC San Diego Moores Cancer Center, La Jolla

92123

RECRUITING

Genesis Research, San Diego

92697

RECRUITING

University of California - Irvine Medical Center, Irvine

97239

RECRUITING

Oregon Health & Science University (OHSU), Portland

08901

RECRUITING

Rutgers Cancer Institute of New Jersey, New Brunswick

08043

RECRUITING

New Jersey Urology, LLC, Voorhees Township

T2V1P9

RECRUITING

Prostate Cancer Centre, Calgary

V5Z1M9

RECRUITING

Vancouver Prostate Centre, Vancouver

B3H2Y9

RECRUITING

Nova Scotia Health Authority, Halifax

M5G 2M9

RECRUITING

University Health Network, Princess Margaret Cancer Centre, Toronto

H4A3J1

RECRUITING

McGill University Health Center - Glen site, Montreal

Unknown

RECRUITING

CHUM Centre Hospitalier de l Universite de Montreal, Montreal

00168

RECRUITING

"Fondazione Policlinico Universitario A.Gemelli IRCCS, Largo", Rome

00189

RECRUITING

Azienda Ospedaliero-Universitaria Sant'Andrea, Rome

53 00144

RECRUITING

"UOC Urologia, IFO- lstituto Tumori Regina Elena", Rome

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

06591

RECRUITING

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

5-7

RECRUITING

IOB - Hospital Quironsalud Barcelona, Barbera Del Valles

08025

RECRUITING

Fundacio Puigvert, Barcelona

08036

RECRUITING

Hospital Clinic Barcelona, Barcelona

08916

RECRUITING

Hospital Germans Trias i Pujol, Barcelona

08907

RECRUITING

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat

SW3 6JJ

RECRUITING

The Royal Marsden NHS Foundation Trust, London

All Listed Sponsors
lead

enGene, Inc.

INDUSTRY