A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG-Unresponsive NMIBC

Brief description of study

The purpose of the study is to evaluate the safety and efficacy of intravesical administration of EG-70 and its effect on bladder tumors in patients with NMIBC in whom BCG therapy has failed and are recommended for radical cystectomy. There are two parts to the study: the first part consists of the dose-escalation phase to establish safety and the second part consists of determining the recommended phase 2 dose. The study drug EG-70i s an investigational drug, which means it has not been approved by the US Food and Drug Administration (FDA), or the regulatory authority in any country, to be used outside of clinical research. The study drug is a type of gene therapy. It includes tiny pieces of DNA, called genes, that are intended to give your immune system new instructions on how to recognize and fight cancer cells. The study drug is a non-viral gene therapy, which means it does not use a modified virus to get into cells and deliver the instructions, like many other gene therapies.You will receive the study drug as a liquid solution directly into your bladder through a tube called a catheter.

Clinical Study Identifier: s20-01771
ClinicalTrials.gov Identifier: NCT04752722

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