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

Active:	Yes
Cancer Type:	Bladder Cancer	NCT ID:	NCT04752722
Trial Phases:	Phase I Phase II	Protocol IDs:	EG-70-101 (primary) NCI-2021-12422
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	enGene, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04752722

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.

Objectives

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.

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