RECRUITING

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

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Conditions

Superficial Bladder CancerNon-muscle Invasive Bladder Cancer With Carcinoma in SituNon-muscle invasive bladder cancer (NMIBC)Bacillus calmette- guerin (BCG) failureBCG unresponsiveNMIBCBladder CancerLEGEND StudyEG-70High-risk NMIBCBCG-naïveIncomplete BCG treatmentCarcinoma in situ (Cis)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-04-22
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04752722

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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 1) persistent disease within 12 months of treatment or 2) a recurrence within 6 months of completion of adequate BCG therapy, 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
  2. 2. 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: a) incomplete BCG (at least 1 dose) treatment or b) no treatment with BCG but who 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 indicated by pathology
  3. 3. Patients who have previously been treated with an investigational or approved checkpoint inhibitor (e.g., pembrolizumab) and failed treatment are eligible for inclusion 30 days post-treatment (Phase 1) or 3 months post-treatment (Phase 2).
  4. 4. Male or non-pregnant, non-lactating female, 18 years or older.
  5. 5. Women of childbearing potential must have a negative pregnancy test at Screening.
  6. 6. Female patients of childbearing potential must be willing to consent to using highly effective birth control methods while on treatment and for 3 months (or longer in accordance with local regulatory requirements) after their participation in the study ends; Male patients are required to utilize a condom for the duration of the study treatment through 3 months post-dose.
  7. 7. In Phase 2, for patients with T1 lesions, Screening biopsy must be considered adequate (contain the muscularis layer).
  8. 8. Performance Status: Eastern Cooperative Oncology Group 0, 1, and 2.
  9. 9. Hematologic inclusion:
  10. 1. Absolute neutrophil count \>1,500/mm3.
  11. 2. Hemoglobin \>9.0 g/dL.
  12. 3. Platelet count \>100,000/mm3.
  13. 10. Hepatic inclusion:
  14. 1. Total bilirubin must be ≤1.5 x the upper limit of normal (ULN).
  15. 2. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤2.5 x ULN.
  16. 11. Adequate renal function with creatinine clearance \>30 mL/min
  17. 12. Prothrombin time and partial thromboplastin time ≤1.25 x ULN or within the therapeutic range if on anticoagulation therapy.
  18. 13. Must have satisfactory bladder function with ability to retain study drug for a minimum of 60 minutes.
  19. 14. Patient or legally authorized representative must be willing and able to comply with all protocol requirements.
  20. 15. Must be willing and able to give informed consent.
  1. 1. Any malignancy (other than NMIBC) diagnosed within 1 year of study entry (except basal or squamous cell skin cancers or noninvasive cancer of the cervix) ), or any malignancy that has required therapy for active disease within the last 12 months.
  2. 2. Concurrent treatment with any chemotherapeutic agent.
  3. 3. History of partial cystectomy.
  4. 4. Treatment with pembrolizumab within 30 days (Phase 1) or 3 months (Phase 2) prior to Screening.
  5. 5. Treatment with last therapeutic agent (including intravesical chemotherapy post-TURBT) within 30 days of Screening.
  6. 6. Evidence of persistent or ongoing renal failure.
  7. 7. History of unresolved vesicoureteral reflux or an indwelling urinary stent.
  8. 8. History of unresolved hydronephrosis due to ureteral obstruction.
  9. 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. 10. History of external beam radiation to the pelvis at any time or prostate brachytherapy within the last 12 months.
  11. 11. History of interstitial lung disease and/or pneumonitis in patients who have previously received a PD-1 or PD-L1 inhibitor therapy.
  12. 12. Evidence of metastatic disease.
  13. 13. History of difficult catheterization that in the opinion of the Investigator will prevent administration of EG-70.
  14. 14. Active interstitial cystitis on cystoscopy or biopsy.
  15. 15. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  16. 16. Known human immunodeficiency virus, Hepatitis B, or Hepatitis C infection.
  17. 17. Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months).
  18. 18. Hypersensitivity to any of the excipients of the study drug.
  19. 19. Consideration by the Investigator that the patient is an unsuitable candidate for the study.

Contacts and Locations

Study Contact

enGene clinical trials
CONTACT
+18572991097
clinicaltrials@engene.com
Chris Tosone
CONTACT

Principal Investigator

Christine Tosone, Ms, RAC
STUDY_DIRECTOR
enGene, Inc.

Study Locations (Sites)

Mayo Clinic Building - Phoenix
Phoenix, Arizona, 85054
United States
Urological Associates of South Arizona
Tucson, Arizona, 85715
United States
University of California - Irvine Medical Center
Irvine, California, 92697
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92037
United States
Urology Group of Southern California / American Institute of Research
Los Angeles, California, 90017
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Tower Urology
Los Angeles, California, 90048
United States
Genesis Research
San Diego, California, 92123
United States
The George Washington Medical Faculty Associates
Washington, District of Columbia, 20037
United States
University of Florida
Jacksonville, Florida, 32209
United States
Emory University
Atlanta, Georgia, 30322
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Chesapeake Urology Research Associates
Hanover, Maryland, 21076
United States
Brigham and Women's Hospital
Boston, Massachusetts, 45227
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Corewell Health Medical Group and Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
New Jersey Urology, LLC
Voorhees, New Jersey, 08043
United States
Mount Sinai Medical Center
New Haven, New York, 10029
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
United States
UNC Chapel Hill Hospital
Chapel Hill, North Carolina, 27514
United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
Clinical Research Solutions - Helios Clinical Research
Middleburg Heights, Ohio, 44130
United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
United States
Urology Associates, P.C.
Nashville, Tennessee, 37209
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Houston Metro Urology
Houston, Texas, 77027
United States
Houston Methodist Hospital - Department of Urology
Houston, Texas, 77030
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
United States
Froedtert Hospital / Medical College of Wisconsin
Milwaukee, Wisconsin, 52336
United States

Collaborators and Investigators

Sponsor: enGene, Inc.

  • Christine Tosone, Ms, RAC, STUDY_DIRECTOR, enGene, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-22
Study Completion Date2027-05

Study Record Updates

Study Start Date2021-04-22
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • 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)

Additional Relevant MeSH Terms

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