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AzTrials

Superficial Bladder CancerPhase 1/2NCT04752722

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

A Phase 1/2 study testing EG-70 (phase 1), EG-70 (phase 2) Master Protocol and Surfactant Bladder Pre-Rinse and EG-70 (Substudy) in people with Superficial Bladder Cancer and Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, run by enGene, Inc. at 102 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will evaluate the safety and efficacy of intravesical administration of detalimogene (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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EG-70 (phase 1), EG-70 (phase 2) Master Protocol and Surfactant Bladder Pre-Rinse and EG-70 (Substudy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
102 sitesin 10 countries
Study dates
22 Apr 2021to 30 Oct 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BCG-unresponsive Patients:
  • 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:
  • 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 with High Grade NMIBC:
Show all 17Show fewer
  • 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).
  • Male or non-pregnant, non-lactating female, 18 years or older.
  • Women of childbearing potential must have a negative pregnancy test at Screening.
  • 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.
  • 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.
  • Performance Status: Eastern Cooperative Oncology Group 0, 1, and 2.
  • Hematologic inclusion: a. Absolute neutrophil count >1,500/mm3. b. Hemoglobin >9.0 g/dL. c. Platelet count >100,000/mm3.
  • 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.
  • Adequate renal function with creatinine clearance >30 mL/min
  • Prothrombin time and partial thromboplastin time ≤1.25 x ULN or within the therapeutic range if on anticoagulation therapy.
  • Must have satisfactory bladder function with ability to retain study drug for 60 minutes.

Who cannot join

  • Active malignancies (i.e., progressing or requiring treatment change in the last 24 months). Exceptions allowed under Sponsor review.
  • Concurrent treatment with any chemotherapeutic agent.
  • History of partial cystectomy.
  • Treatment with last therapeutic agent (including intravesical chemotherapy post-TURBT) within 30 days of Screening (prior to the screening biopsy).
  • Patients who have received systemic immunosuppressive medication including high-dose corticosteroids.
  • History of severe asthma or other respiratory diseases.
Show all 19Show fewer
  • History of unresolved vesicoureteral reflux or an indwelling urinary stent.
  • History of unresolved hydronephrosis due to ureteral obstruction.
  • 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.
  • History of external beam radiation to the pelvis or prostate brachytherapy within the last 12 months.
  • History of interstitial lung disease and/or pneumonitis in patients who have previously received a PD-1 or PD-L1 inhibitor therapy.
  • Evidence of metastatic disease.
  • History of difficult catheterization that in the opinion of the Investigator will prevent administration of EG-70.
  • Active interstitial cystitis on cystoscopy or biopsy.
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  • Known human immunodeficiency virus, Hepatitis B, or Hepatitis C infection.
  • Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months).
  • Hypersensitivity to any of the excipients of the study drug.
  • Exclusionary for Bladder Rinse cohorts: known allergy to polidocanol

Trial locations and contacts

102 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

enGene clinical trials contact

+18572991097

clinicaltrials@engene.com

Chris Tosone contact

102 sites in 10 countries

United States50 sites, 48 recruiting

  • Albany Medical College

    Albany, New York, 12208

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Shreyas Joshi, 404-778-4898, shreyas.joshi@emory.edu

    Recruiting

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

    Recruiting

  • Urology Austin

    Austin, Texas, 78745

    Recruiting

  • John Hopkins Hospital

    Baltimore, Maryland, 21287

    Recruiting

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

    Birmingham, Alabama, 35249

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 45227

    Mark Preston, MPRESTON@BWH.HARVARD.EDU

    Saachi Pawa, 617-525-8793, bwhurologyrcs@partners.org

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Recruiting

  • UNC Chapel Hill Hospital

    Chapel Hill, North Carolina, 27514

    Marc Bjurlin, 919-966-8217, marc_bjurlin@med.unc.edu

    Recruiting

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22903

    Christine Ibilibor, ci5d@uvahealth.org

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Mohammed Kamel, 513-558-0983, kamelme@ucmail.uc.edu

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Jose Santoyo, 214-645-8764, jose.santoyo@utsouthwestern.edu

    Yair Lotan, Yair.Lotan@UTSouthwestern.edu

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Johar Raza, MD, 716-697-0305, jraza1@hfhs.org

    Recruiting

  • Duke Health - Duke Cancer Center

    Durham, North Carolina, 27710

    Recruiting

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230

    Recruiting

  • Corewell Health Medical Group and Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503

    Conrad Tobert, 616-267-7333

    Recruiting

  • Urology of Indiana

    Greenwood, Indiana, 46143

    Recruiting

  • Chesapeake Urology Research Associates

    Hanover, Maryland, 21076

    Rian Dickstein, rdickstein@cua.md

    Recruiting

  • Houston Metro Urology

    Houston, Texas, 77027

    Gelpi-Hammerschmidt

    Recruiting

  • Houston Methodist Hospital - Department of Urology

    Houston, Texas, 77030

    Taliah Muhammad, 346-238-4523, tnmuhammad@houstonmethodist.org

    Recruiting

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

    Ashish Kamat, MD, 713-792-3250, akamat@mdanderson.org

    Recruiting

  • University of California - Irvine Medical Center

    Irvine, California, 92697

    Edward Uchio, euchio@uci.edu

    Recruiting

  • University of Florida

    Jacksonville, Florida, 32209

    Kethandapatti Balaji, 904-244-7340, kc.balaji@jax.ufl.edu

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Faith Rahman, 913-588-2502, frahman2@kumc.edu

    Laura Mitchell, 913-574-2854, Lmitchell11@kumc.edu

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037

    Salmasi

    Recruiting

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

    Recruiting

  • Arkansas Urology

    Little Rock, Arkansas, 72211

    Recruiting

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Anne Schuckman, 323-865-3700, anne.schuckman@med.usc.edu

    Recruiting

  • Tower Urology

    Los Angeles, California, 90048

    Terry Williams, 310-854-9898 ext. 178, williamst@towerurology.com

    Recruiting

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

    Miami, Florida, 33136

    Recruiting

  • Clinical Research Solutions - Helios Clinical Research

    Middleburg Heights, Ohio, 44130

    Kara Lasorella, 440-340-9010, kara.lasorella@heliosclinical.com

    Recruiting

  • Froedtert Hospital / Medical College of Wisconsin

    Milwaukee, Wisconsin, 52336

    Scott Johnson, 414-955-0867, scjohnson@mcw.edu

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Marissa Twedt, 612-626-6661, twedt050@umn.edu

    Joseph Zabell, zabe0034@umn.edu

    Recruiting

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572

    Neal Shore, 843-449-1010, nshore@auclinics.com

    Recruiting

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

    Jayram

    Recruiting

  • Vanderbilt Univerity Medical Center

    Nashville, Tennessee, 37232

    Chang

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Packiam

    Recruiting

  • Mount Sinai Medical Center

    New Haven, New York, 10029

    John Sfakianos, john.sfakianos@mountsinai.or

    Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

    Completed

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239

    J Liu, 610-659-7113, jenj@ohsu.edu

    Recruiting

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612

    Mark Jalkut, 919-782-1255, mjalkut@gmail.com

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Shah

    Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

    Recruiting

  • Om Research

    San Diego, California, 92123

    Alanna Gavriushina, 858-430-1101 ext. 2670, Alanna.gavriushina@uniohp.com

    Katayune Golshan, Katayune.golshan@uniohp.com

    Recruiting

  • Mayo Clinic

    Scottsdale, Arizona, 85259

    Recruiting

  • Associated Medical Professionals of NY,

    Syracuse, New York, 13210

    Recruiting

  • Urological Associates of South Arizona

    Tucson, Arizona, 85715

    Completed

  • New Jersey Urology, LLC

    Voorhees Township, New Jersey, 08043

    Gordon Brown, gbrown@njurology.com

    Recruiting

  • The George Washington Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

    Michael Whalen, 202-741-2798, mwhalen@mfa.gwu.edu

    Recruiting

Other trials in United States

Spain12 sites, 12 recruiting

  • IOB - Hospital Quironsalud Barcelona

    Barbera Del Valles, 5-7

    Recruiting

  • Fundacio Puigvert

    Barcelona, 08025

    Recruiting

  • Hospital Clinic Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital Germans Trias i Pujol

    Barcelona, 08916

    Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907

    Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital Quironsalud Madrid (Next Oncology)

    Madrid, 28223

    Recruiting

  • Hospital Universitario Infanta Sofia

    Madrid, 28702

    Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

    Recruiting

  • Hospital Universitario Marqués de Valdecilla,

    Santander, 39008

    Recruiting

Other trials in Spain

France7 sites, 7 recruiting

  • CHU d'Angers

    Angers, 49933

    Recruiting

  • CHU Bordeaux Pellegrin

    Bordeaux, 33076

    Recruiting

  • lnstitut Bergonie 229 Cour de l'Argonne

    Bordeaux, 33076

    Recruiting

  • CHU de Lille

    Lille, 59000

    Recruiting

  • Hospices Civils de Lyon

    Lyon, 69002

    Recruiting

  • Hopital Bichat Claude-Bernard

    Paris, 75018

    Recruiting

  • CHU de Rauen- Hopital Charles Nicolle

    Rouen, 76031

    Recruiting

Other trials in France

Italy7 sites, 7 recruiting

  • Clinic Unit of Urology, IRCCS Ospedale San Raffaele

    Milan, MI, 20132

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, 20141

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, 80131

    Recruiting

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

    Rome, 00168

    Recruiting

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Rome, 00189

    Recruiting

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

    Rome, 53 00144

    Recruiting

  • Ospedelae Molinette San Giovanni Battista Di Torino

    Torino, 10126

    Recruiting

Other trials in Italy

Canada6 sites, 6 recruiting

  • Prostate Cancer Centre

    Calgary, Alberta, T2V1P9

    Recruiting

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H2Y9

    Ricardo Rendon, Ricardo.Rendon@nshealth.ca

    Robin Simpson, robin.simpson@nshealth.ca

    Recruiting

  • McGill University Health Center - Glen site

    Montreal, Quebec, H4A3J1

    W Kassouf, 514-934-1934, wassim.kassouf@mcgill.ca

    K Jaureguisanchez, 514-934-1934 ext. 34905, Karla.Jaureguisanchez@muhc.mcgill.ca

    Recruiting

  • CHUM Centre Hospitalier de l Universite de Montreal

    Montreal, Quebec

    Recruiting

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

  • Vancouver Prostate Centre

    Vancouver, British Columbia, V5Z1M9

    Recruiting

Other trials in Canada

Germany6 sites, 6 recruiting

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

    Cologne, 50937

    Recruiting

  • Urologicum Duisburg

    Duisburg, 47169

    Recruiting

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

    Recruiting

  • Urologie Neandertal Mettmann

    Mettmann, 40822

    Recruiting

  • Studienpraxis Urologie

    Nürtingen, 72622

    Recruiting

  • Universitaetsklinikum Tubingen

    Tübingen, 72076

    Recruiting

Other trials in Germany

South Korea5 sites, 5 recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, Gyunggi-do, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

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

    Seoul, 06591

    Recruiting

Other trials in South Korea

Taiwan5 sites, 5 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Recruiting

  • China Medical University Hospital

    Taichung, 40447

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Recruiting

  • Chi Mei Medical Center

    Tainan, 71004

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

Other trials in Taiwan

Australia3 sites, 3 recruiting

  • Gold Coast University Hospital

    Southport, Queensland, 4215

    Recruiting

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

    Recruiting

  • Icon Cancer Center Windsor Gardens

    Windsor Gardens, South Australia, 5087

    Recruiting

Other trials in Australia

United Kingdom1 site, 1 recruiting

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

    Recruiting

Other trials in United Kingdom

About this study

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

This study will evaluate the safety and efficacy of intravesical administration of detalimogene (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 other high risk patients with NMIBC.

A Substudy will include a surfactant bladder rinse prior to the instillation of detalimogene in patients with NMIBC with CIS for whom BCG therapy is unresponsive.

Read the 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 with CIS patients will be enrolled in Phase 1, and Cohort 1 of Phase 2. Eligible high-risk NMIBC patients will be enrolled in Phase 2 into separate cohorts include: BCG-naïve patients or BCG-exposed (incompletely treated) patients with Carcinoma in situ (CIS), and BCG-unresponsive HG Ta/T1 papillary disease without CIS.

Patients will be treated for up to four 12-week cycles of study drug instillation doses and assessments with follow up assessments. Patients with complete response following four treatment cycles will enter up to 8 maintenance treatment cycles.

Being tested
EG-70 (phase 1), EG-70 (phase 2) Master Protocol, Surfactant Bladder Pre-Rinse and EG-70 (Substudy)
Keywords
Non-muscle invasive bladder cancer (NMIBC), Bacillus calmette- guerin (BCG) failure, BCG-unresponsive, NMIBC, Bladder Cancer, LEGEND Study, EG-70, High-risk NMIBC, BCG-naïve, Incomplete BCG treatment, Carcinoma in situ (Cis), BCG-exposed, Surfactant Bladder Rinse, Bladder Rinse
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Carcinoma in Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EG-70 (phase 1)Drug

    Also called 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.

  • EG-70 (phase 2) Master ProtocolDrug

    Also called Phase 2

    Under the Treatment Period, patients will receive 4 instillations per cycle for 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.

  • Surfactant Bladder Pre-Rinse and EG-70 (Substudy)Drug

    Also called Phase 1 Bladder Rinse, Surfactant

    Patients will receive via catheter a 50 mL volume of a 5-minute bladder rinse immediately prior to administration of 50 mL of detalimogene voraplasmid (EG-70) at the RP2D for 30 minutes.

    During the Treatment Period, patients will receive 4 instillations per cycle for up to 4 cycles of the sudy intervention. One cycle lasts approximately 12 weeks. For Maintenance treatment, 2 doses of the study intervention will be administered as a bladder instillation per 12-week cycle.

Study groups in NCT04752722
Study groupRoleWhat they receive
Phase 1ExperimentalDose escalation phase
Receives: Drug: EG-70 (phase 1)
Phase 2ExperimentalCohort 1: Recommended Phase 2 dose (RP2D) with eligible BCG-unresponsive NMIBC patients with CIS, up to 4 cycles of treatment with EG-70. Patients in Complete Response continue to Maintenance Treatment. Cohorts 2A, 2B and 3: RP2D with eligible high-risk NMIBC patients with CIS who are BCG-naïve, BCG-exposed (incompletely treated with BCG) or BCG-unresponsive HG Ta/T1 papillary disease without CIS
Receives: Drug: EG-70 (phase 2) Master Protocol
Phase 1 Substudy Surfactant Bladder RinseExperimentalBCG-unresponsive NMIBC patients with CIS, up to 4 cycles of treatment with EG-70. Patients in Complete Response continue to Maintenance Treatment. Bladder Rinse Cohort: a 5-minute bladder rinse prior to administration of RP2D of detalimogene voraplasmid (EG-70) with a shortened administration time of 30 minutes.
Receives: Drug: Surfactant Bladder Pre-Rinse and EG-70 (Substudy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0.

    The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored.

    Measured: Approximately 2 years

  2. Phase 2: Percentage of patients with cystoscopic CR at any time, based on exam, urine cytology and appropriate biopsies.

    Complete response rate will be measured by determining the number of patients without recurrence of disease.

    Measured: Approximately 24 weeks

  3. Phase 2: Nature, incidence, relatedness, and severity of treatment emergent adverse events (as assessed by CTCAE v5.0)

    The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored.

    Measured: Approximately 3 years

Secondary outcomes (6)

  1. Phase 1: The number of patients who experience a DLT through the end of Cycle 1

    To identify the number of patients who experience a DLT through the end of Cycle 1

    Measured: Approximately 12 Weeks

  2. Phase 1: CR rate to EG-70 by cystoscopy at approximately 12 weeks.

    To evaluate preliminary efficacy of EG-70 by 12 weeks via cystoscopy

    Measured: Approximately 12 weeks

  3. Phase 2: Duration of response of the responding patients

    Durability will be measured by determining the number of patients without recurrence of high-grade disease.

    Measured: Approximately 3 years

  4. Phase 2: Progression-free survival (PFS)

    To evaluate disease-free survival rate

    Measured: Approximately 3 years

  5. Phase 2: CR rate at 12, 24, 36, and 96 weeks

    To further evaluate CR at the efficacy analysis following each cycle.

    Measured: Approximately 12, 24, 36, and 96 weeks

  6. Phase 2: Quality of Life Assessment

    Health-related quality of life

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start22 Apr 2021
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04752722
Sponsor's protocol ID
EG-70-101
Status last verified
Aug 2026
First submitted
4 Feb 2021
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EG-70 (phase 1), EG-70 (phase 2) Master Protocol and Surfactant Bladder Pre-Rinse and EG-70 (Substudy) in people with Superficial Bladder Cancer and Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, run by enGene, Inc. at 102 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Spain, France, Italy, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact enGene clinical trials (+18572991097, clinicaltrials@engene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0. (time frame: Approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04752722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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