Bladder Cancer Clinical Trial

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

Summary

This open-label, multicenter study will evaluate the safety and efficacy of intravesical administration of EG-70 and its effect on bladder tumors in patients with NMIBC who have failed BCG therapy and are recommended for radical cystectomy or high-risk NMIBC patients who are BCG-naïve or have received incomplete BCG treatment. This study study consists of two phases, a dose-escalation Phase (Phase 1) to establish safety and recommended phase 2 dose (RP2D), followed by a Phase 2 efficacy study at the RP2D to establish efficacy. Eligible BCG-unresponsive NMIBC patients will be enrolled in Phase 1, and Cohort 1 of Phase 2. Eligible high-risk NMIBC patients who have been incompletely treated or are BCG-naïve will be enrolled starting in Phase 2 in a separate single-arm cohort (Cohort 2).

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Full 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 patients will be enrolled in Phase 1, and Cohort 1 of Phase 2. Eligible high-risk NMIBC patients who have been incompletely treated or are BCG-naïve will be enrolled starting in Phase 2 in a separate single-arm cohort (Cohort 2).

Patients will be treated for up to four 12-week cycles of study drug instillation doses and assessments with follow up assessments.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 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

BCG-Naïve or BCG-incompletely treated Patients (Phase 2 Only):

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

All Patients:

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).
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 effective double-barrier contraception 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.
In Phase 2, for patients with T1 lesions, Screening biopsy must be considered adequate (contain the muscularis layer).
Performance Status: Eastern Cooperative Oncology Group 0, 1, and 2.

Hematologic inclusion:

Absolute neutrophil count >1,500/mm3.
Hemoglobin >9.0 g/dL.
Platelet count >100,000/mm3.

Hepatic inclusion:

Total bilirubin must be ≤1.5 x the upper limit of normal (ULN).
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 a minimum of 60 minutes.
Patient or legally authorized representative must be willing and able to comply with all protocol requirements.
Must be willing and able to give informed consent.

Exclusion Criteria:

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.
Concurrent treatment with any chemotherapeutic agent.
History of partial cystectomy.
Treatment with pembrolizumab within 30 days (Phase 1) or 3 months (Phase 2) prior to Screening.
Treatment with last therapeutic agent (including intravesical chemotherapy post-TURBT) within 30 days of Screening.
Evidence of persistent or ongoing renal failure.
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 at any time 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).
Consideration by the Investigator that the patient is an unsuitable candidate for the study.

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

222

Study ID:

NCT04752722

Recruitment Status:

Recruiting

Sponsor:

enGene, Inc.

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There are 26 Locations for this study

See Locations Near You

Urological Associates of South Arizona
Tucson Arizona, 85715, United States More Info
Susan Kalota
Contact
520-795-5830
[email protected]
University of California - Irvine Medical Center
Irvine California, 92697, United States More Info
Edward Uchio
Contact
[email protected]
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 More Info
Anne Schuckman
Contact
323-865-3700
[email protected]
Tower Urology
Los Angeles California, 90048, United States More Info
Terry Williams
Contact
310-854-9898
[email protected]
Genesis Research
San Diego California, 92123, United States More Info
Alanna Gavriushina
Contact
858-430-1101
[email protected]
Katayune Golshan
Contact
[email protected]
The George Washington Medical Faculty Associates
Washington District of Columbia, 20037, United States More Info
Michael Whalen
Contact
202-741-2798
[email protected]
University of Florida
Jacksonville Florida, 32209, United States More Info
Kethandapatti Balaji
Contact
904-244-7340
[email protected]
Emory University
Atlanta Georgia, 30322, United States More Info
Shreyas Joshi
Contact
404-778-4898
[email protected]
University of Kansas Medical Center
Kansas City Kansas, 66160, United States More Info
Faith Rahman
Contact
913-588-2502
[email protected]
Laura Mitchell
Contact
913-574-2854
[email protected]
Chesapeake Urology Research Associates
Hanover Maryland, 21076, United States More Info
Rian Dickstein
Contact
[email protected]
Henry Ford Health System
Detroit Michigan, 48202, United States More Info
Johar Raza, MD
Contact
716-697-0305
[email protected]
Corewell Health Medical Group and Spectrum Health Hospitals
Grand Rapids Michigan, 49503, United States More Info
Conrad Tobert
Contact
616-267-7333
[email protected]
University of Minnesota
Minneapolis Minnesota, 55455, United States More Info
Marissa Twedt
Contact
612-626-6661
[email protected]
Joseph Zabell
Contact
[email protected]
New Jersey Urology, LLC
Voorhees New Jersey, 08043, United States More Info
Gordon Brown
Contact
[email protected]
Mount Sinai Medical Center
New Haven New York, 10029, United States More Info
John Sfakianos
Contact
[email protected]
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 More Info
Marc Bjurlin
Contact
919-966-8217
[email protected]
Associated Urologists of North Carolina
Raleigh North Carolina, 27612, United States More Info
Mark Jalkut
Contact
919-782-1255
[email protected]
University of Cincinnati Medical Center
Cincinnati Ohio, 45219, United States More Info
Mohammed Kamel
Contact
513-558-0983
[email protected]
Clinical Research Solutions - Helios Clinical Research
Middleburg Heights Ohio, 44130, United States More Info
Kara Lasorella
Contact
440-340-9010
[email protected]
Oregon Health & Science University (OHSU)
Portland Oregon, 97239, United States More Info
Carolina Urologic Research Center, LLC
Myrtle Beach South Carolina, 29572, United States More Info
Neal Shore
Contact
843-449-1010
[email protected]
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Jose Santoyo
Contact
214-645-8764
[email protected]
Yair Lotan
Contact
[email protected]
Houston Methodist Hospital - Department of Urology
Houston Texas, 77030, United States More Info
Taliah Muhammad
Contact
346-238-4523
[email protected]
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Ashish Kamat, MD
Contact
713-792-3250
[email protected]
Froedtert Hospital / Medical College of Wisconsin
Milwaukee Wisconsin, 52336, United States More Info
Scott Johnson
Contact
414-955-0867
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

222

Study ID:

NCT04752722

Recruitment Status:

Recruiting

Sponsor:


enGene, Inc.

How clear is this clinincal trial information?

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