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 Unknown Primary	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
detalimogene (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 other high risk patients with NMIBC.

A Substudy will include a surfactant bladder rinse prior to the instillation of
detalimogene in patients with NMIBC with CIS for whom BCG therapy is unresponsive.

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 with CIS patients will be enrolled in Phase 1, and Cohort
1 of Phase 2. Eligible high-risk NMIBC patients will be enrolled in Phase 2 into separate
cohorts include: BCG-naïve patients or BCG-exposed (incompletely treated) patients with
Carcinoma in situ (CIS), and BCG-unresponsive HG Ta/T1 papillary disease without CIS.

Patients will be treated for up to four 12-week cycles of study drug instillation doses
and assessments with follow up assessments. Patients with complete response following
four treatment cycles will enter up to 8 maintenance treatment cycles.

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