Actively Recruiting
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
Led by enGene, Inc. · Updated on 2026-04-30
350
Participants Needed
101
Research Sites
397 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BCG-unresponsive NMIBC patients with carcinoma in situ (CIS) who are ineligible for or have chosen not to undergo cystectomy, with disease present within 12 months after adequate BCG treatment
- BCG-nafve or incompletely treated high-risk NMIBC patients with CIS or BCG-unresponsive high-grade Ta/T1 papillary disease without CIS (Phase 2 only)
- Patients who failed prior checkpoint inhibitor therapy and are at least 30 days (Phase 1) or 3 months (Phase 2) post-treatment
- Male or non-pregnant, non-lactating female aged 18 years or older
- Women of childbearing potential must have a negative pregnancy test at screening
- Females of childbearing potential must agree to use highly effective birth control; males must use condoms during treatment and for 3 months after
- Patients with T1 lesions may be eligible after repeat TURBT if pathology shows non-invasive or no disease (Phase 2)
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Adequate blood counts: neutrophils >1,500/mm3, hemoglobin >9.0 g/dL, platelets >100,000/mm3
- Liver function: total bilirubin ≤1.5 times upper limit of normal (ULN); AST, ALT, alkaline phosphatase ≤2.5 times ULN
- Adequate kidney function with creatinine clearance >30 mL/min
- Prothrombin time and partial thromboplastin time ≤1.25 times ULN or within therapeutic range if on anticoagulants
- Satisfactory bladder function able to retain study drug for 60 minutes
You will not qualify if you...
- Active cancers progressing or requiring treatment changes in the last 24 months (exceptions possible)
- Receiving chemotherapy currently
- History of partial cystectomy
- Treatment with last therapeutic agent within 30 days before screening biopsy
- Use of systemic immunosuppressive medications including high-dose corticosteroids
- History of severe asthma or other respiratory diseases
- Unresolved vesicoureteral reflux or indwelling urinary stent
- Unresolved hydronephrosis due to ureteral obstruction
- Participation in other investigational drug studies within 30 days prior to screening or prior investigational gene or immunotherapy for NMIBC
- Pelvic or prostate radiation within the last 12 months
- History of interstitial lung disease or pneumonitis in patients previously treated with PD-1 or PD-L1 inhibitors
- Evidence of metastatic disease
- History of difficult catheterization preventing EG-70 administration
- Active interstitial cystitis on cystoscopy or biopsy
- Active uncontrolled infections requiring systemic therapy
- Known HIV, Hepatitis B, or Hepatitis C infection
- Significant cardiovascular risk, such as recent coronary stenting or myocardial infarction
- Allergic reaction to any components of the study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 101 locations
1
The University of Alabama at Birmingham Clinical Research Unit (CRU)
Birmingham, Alabama, United States, 35249
Actively Recruiting
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Actively Recruiting
3
Urological Associates of South Arizona
Tucson, Arizona, United States, 85715
Completed
4
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Actively Recruiting
5
University of California - Irvine Medical Center
Irvine, California, United States, 92697
Actively Recruiting
6
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
7
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
8
Tower Urology
Los Angeles, California, United States, 90048
Actively Recruiting
9
Om Research
San Diego, California, United States, 92123
Actively Recruiting
10
Colorado Clinical Research
Lakewood, Colorado, United States, 80228
Actively Recruiting
11
The George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
12
University of Florida
Jacksonville, Florida, United States, 32209
Actively Recruiting
13
Sylvester Comprehensive Cancer Center / University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
Actively Recruiting
14
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
15
Rush University Medical Center
Chicago, Illinois, United States, 60607
Actively Recruiting
16
Urology of Indiana
Greenwood, Indiana, United States, 46143
Actively Recruiting
17
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
18
John Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
19
Chesapeake Urology Research Associates
Hanover, Maryland, United States, 21076
Actively Recruiting
20
Brigham and Women's Hospital
Boston, Massachusetts, United States, 45227
Actively Recruiting
21
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
22
Corewell Health Medical Group and Spectrum Health Hospitals
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
23
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
24
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
25
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
26
New Jersey Urology, LLC
Voorhees Township, New Jersey, United States, 08043
Actively Recruiting
27
Albany Medical College
Albany, New York, United States, 12208
Actively Recruiting
28
Mount Sinai Medical Center
New Haven, New York, United States, 10029
Actively Recruiting
29
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Completed
30
Associated Medical Professionals of NY,
Syracuse, New York, United States, 13210
Actively Recruiting
31
UNC Chapel Hill Hospital
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
32
Duke Health - Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
33
Associated Urologists of North Carolina
Raleigh, North Carolina, United States, 27612
Actively Recruiting
34
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
35
Central Ohio Urology Group
Gahanna, Ohio, United States, 43230
Actively Recruiting
36
Clinical Research Solutions - Helios Clinical Research
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
37
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
38
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
39
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
40
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
Actively Recruiting
41
Vanderbilt Univerity Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
42
Urology Austin
Austin, Texas, United States, 78745
Actively Recruiting
43
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
44
Houston Metro Urology
Houston, Texas, United States, 77027
Actively Recruiting
45
Houston Methodist Hospital - Department of Urology
Houston, Texas, United States, 77030
Actively Recruiting
46
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
47
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
48
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
49
Froedtert Hospital / Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 52336
Actively Recruiting
50
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Actively Recruiting
51
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
52
Icon Cancer Center Windsor Gardens
Windsor Gardens, South Australia, Australia, 5087
Actively Recruiting
53
Prostate Cancer Centre
Calgary, Alberta, Canada, T2V1P9
Actively Recruiting
54
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z1M9
Actively Recruiting
55
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H2Y9
Actively Recruiting
56
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
57
McGill University Health Center - Glen site
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
58
CHUM Centre Hospitalier de l Universite de Montreal
Montreal, Quebec, Canada
Actively Recruiting
59
CHU d'Angers
Angers, France, 49933
Actively Recruiting
60
CHU Bordeaux Pellegrin
Bordeaux, France, 33076
Actively Recruiting
61
lnstitut Bergonie 229 Cour de l'Argonne
Bordeaux, France, 33076
Actively Recruiting
62
CHU de Lille
Lille, France, 59000
Actively Recruiting
63
Hospices Civils de Lyon
Lyon, France, 69002
Actively Recruiting
64
Hopital Bichat Claude-Bernard
Paris, France, 75018
Actively Recruiting
65
CHU de Rauen- Hopital Charles Nicolle
Rouen, France, 76031
Actively Recruiting
66
Klinik fur Urologie, Uro-Onkologie, spezielle urologische und Roboter-assistierte Chirurgie Universitatsklinikum Koln (AOR)
Cologne, Germany, 50937
Actively Recruiting
67
Urologicum Duisburg
Duisburg, Germany, 47169
Actively Recruiting
68
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
69
Urologie Neandertal Mettmann
Mettmann, Germany, 40822
Actively Recruiting
70
Studienpraxis Urologie
Nürtingen, Germany, 72622
Actively Recruiting
71
Universitaetsklinikum Tubingen
Tübingen, Germany, 72076
Actively Recruiting
72
Clinic Unit of Urology, IRCCS Ospedale San Raffaele
Milan, MI, Italy, 20132
Actively Recruiting
73
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
74
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
75
Fondazione Policlinico Universitario "A.Gemelli" IRCCS, Largo
Rome, Italy, 00168
Actively Recruiting
76
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, Italy, 00189
Actively Recruiting
77
UOC Urologia, IFO- lstituto Tumori "Regina Elena"
Rome, Italy, 53 00144
Actively Recruiting
78
Ospedelae Molinette San Giovanni Battista Di Torino
Torino, Italy, 10126
Actively Recruiting
79
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, South Korea, 13620
Actively Recruiting
80
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 58128
Actively Recruiting
81
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
82
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
83
The Catholic University of Korea, Soul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
84
IOB - Hospital Quironsalud Barcelona
Barbera Del Valles, Spain, 5-7
Actively Recruiting
85
Fundacio Puigvert
Barcelona, Spain, 08025
Actively Recruiting
86
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Actively Recruiting
87
Hospital Germans Trias i Pujol
Barcelona, Spain, 08916
Actively Recruiting
88
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain, 08907
Actively Recruiting
89
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
90
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
91
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
92
Hospital Quironsalud Madrid (Next Oncology)
Madrid, Spain, 28223
Actively Recruiting
93
Hospital Universitario Infanta Sofia
Madrid, Spain, 28702
Actively Recruiting
94
Hospital General Universitario Morales Meseguer
Murcia, Spain, 30008
Actively Recruiting
95
Hospital Universitario Marqués de Valdecilla,
Santander, Spain, 39008
Actively Recruiting
96
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
97
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
98
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
99
Chi Mei Medical Center
Tainan, Taiwan, 71004
Actively Recruiting
100
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
101
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
Research Team
E
enGene clinical trials
CONTACT
C
Chris Tosone
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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