Virus Therapy

EG-70 for Bladder Cancer

Clinical Research Solutions, Middleburg Heights, OH
EG-70Phase 1 & 2RecruitingResearch Sponsored by enGene, Inc.

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.

Eligible Conditions
  • Superficial Bladder Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have previously received BCG treatment for your condition and it did not work.
Select...
You have a persistent or recurring high-grade disease in your bladder within 6 months of receiving some treatment but not completing the full course.
Select...
You have a specific type of bladder cancer called carcinoma in situ (CIS) that has not responded to previous treatment with BCG. You may or may not have other tumors in the bladder. You are being considered for, unable to have, or have chosen not to have surgery to remove the bladder.
Select...
You have a type of bladder disease that has not improved after receiving a specific treatment called intravesical BCG, or it has come back after at least a year of receiving this 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 site

Who is running the clinical trial?

enGene, Inc.Lead Sponsor
Christine Tosone, MsStudy Director
enGene, 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
Recent research and studies
clinicaltrials.govStudy
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
2021. "LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04752722.
All > Paid Studies Ohio > Milwaukee
~86 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top