This open-label, multicenter study will evaluate the safety and efficacy of intravesical
administration of EG-70 and its effect on bladder tumors in patients with NMIBC who have
failed BCG therapy and are recommended for radical cystectomy or high-risk NMIBC patients who
are BCG-naïve or have received incomplete BCG treatment. This study study consists of two
phases, a dose-escalation Phase (Phase 1) to establish safety and recommended phase 2 dose
(RP2D), followed by a Phase 2 efficacy study at the RP2D to establish efficacy. 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).
EG-70 is a novel non-viral gene therapy. EG-70 is designed to elicit a local immune response
following delivery of gene therapies to mucosal tissues, such as 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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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