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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04752722
Study type Interventional
Source enGene, Inc.
Contact enGene clinical trials
Phone +18572991097
Email clinicaltrials@engene.com
Status Recruiting
Phase Phase 1/Phase 2
Start date April 22, 2021
Completion date May 2027

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