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Virus Therapy

EG-70 for Bladder Cancer

Phase 1 & 2
Recruiting
Research Sponsored by enGene, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hepatic inclusion within 2 weeks of Day 1: Total bilirubin must be ≤1.5 x the upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN for the institution, alkaline phosphatase ≤2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis, Adequate renal function with creatinine clearance >30 mL/min, Prothrombin time and partial thromboplastin time within the normal limits at Screening, Must have satisfactory bladder function with ability to retain study drug for a minimum of 60 minutes, Patient or legally authorized representative (LAR) must be willing and able to comply with all protocol requirements, Patient or LAR must be willing and able to give informed consent and any authorizations required by local law for participation in the study
Patients who have previously been treated with an investigational or approved checkpoint inhibitor and failed treatment are eligible for inclusion 30 days post-treatment (Phase 1) or 3 months post-treatment (Phase 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights

Study Summary

This trial is testing a new treatment for patients with NMIBC who have failed BCG therapy or who are BCG-naïve. The trial has two phases: a dose-escalation phase to establish safety and a Phase 2 efficacy study. Eligible patients will be enrolled in either Phase 1 or Phase 2.

Who is the study for?
This trial is for adults with non-muscle invasive bladder cancer (NMIBC) who haven't responded to BCG therapy or haven't completed it, or are BCG-naïve. They should be able to hold the treatment in their bladder for at least an hour and meet certain health criteria like good liver and kidney function, stable blood counts, no severe infections, and not pregnant. People with a history of certain other medical conditions or treatments are excluded.Check my eligibility
What is being tested?
The LEGEND study is testing EG-70 given directly into the bladder to see if it's safe and effective against NMIBC tumors. The trial has two parts: first finding the right dose (Phase 1), then checking how well it works (Phase 2). Participants will either have been unresponsive to prior BCG therapy or never had it.See study design
What are the potential side effects?
Specific side effects of EG-70 aren't listed here but generally, intravesical therapies can cause urinary symptoms like discomfort during urination, increased frequency or urgency, possible risk of infection due to catheter use, and rarely allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was treated with a checkpoint inhibitor and it didn't work, but it's been 30 days (Phase 1) or 3 months (Phase 2) since then.
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My biopsy for a small tumor was thorough and included the muscle layer.
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I can take care of myself but may not be able to do heavy physical work.
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I am an adult over 18 and not pregnant or breastfeeding.
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I have bladder cancer that hasn't responded to BCG treatment and I can't or won't have bladder removal surgery.
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I have bladder cancer, haven't had much BCG treatment, and can't or won't have surgery.
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My blood counts meet the required levels for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0.
Phase 2: Nature, incidence, relatedness, and severity of treatment emergent adverse events (as assessed by CTCAE v5.0)
Phase 2: Percentage of patients with cystoscopic CR at 48 weeks, based on exam, urine cytology and appropriate biopsies.
Secondary outcome measures
Phase 1: CR rate to EG-70 by cystoscopy at approximately 12 weeks.
Phase 1: The number of patients who experience a DLT through the end of Cycle 1
Phase 2: CR rate at 12, 24, 36, and 96 weeks
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment1 Intervention
Cohort 1: Recommended Phase 2 dose (RP2D) with eligible BCG-unresponsive NMIBC patients, up to 4 cycles of treatment with EG-70 Cohort 2: RP2D with eligible high-risk NMIBC patients who have been incompletely treated with BCG or are BCG-naïve
Group II: Phase 1Experimental Treatment1 Intervention
Dose escalation phase

Find a Location

Who is running the clinical trial?

enGene, Inc.Lead Sponsor
Christine Tosone, Ms, RACStudy DirectorenGene, Inc.
Christine Tosone, MsStudy DirectorenGene, Inc.

Media Library

EG-70 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04752722 — Phase 1 & 2
Bladder Cancer Research Study Groups: Phase 2, Phase 1
Bladder Cancer Clinical Trial 2023: EG-70 Highlights & Side Effects. Trial Name: NCT04752722 — Phase 1 & 2
EG-70 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752722 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people with the relevant medical condition participate in this trial now?

"Yes, this clinical trial is still recruiting patients. The most recent update on the progress of the trial was posted on 5/11/2022, and recruitment began on 4/22/2021."

Answered by AI

How many people can potentially enroll in this research project?

"That is accurate. The clinical trial, which was first announced on April 22nd 2021, is still recruiting patients as of May 11th 2022. They are looking for a total of 222 people to participate at 8 different locations."

Answered by AI

What are the primary goals of this clinical trial?

"The primary goal of this study, which will last approximately 48 weeks, is to Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0.. Additionally, researchers are looking at secondary outcomes including Phase 2: Progression-free survival (PFS), Phase 1: The number of patients who experience a DLT through the end of Cycle 1 , andPhase 2: Duration of response of the responding patients."

Answered by AI

Are there different research hospitals participating in this clinical trial across Canada?

"In addition to Laura & Isaac Perlmutter Cancer Center at NYU Langone Health in New york, this trial is also running out of New jersey Urology, LLC in Voorhees and UT Southwestern Medical Center in Dallas. There are a total of 8 different locations for this study."

Answered by AI
~63 spots leftby Jun 2025