CG Oncology | CORE-008 | NCT06567743

About

High-risk non-muscle invasive bladder cancer (NMIBC) is a form of bladder cancer confined to the bladder lining but with features associated with a high likelihood of returning or progressing. It affects tens of thousands of Americans annually. The standard first-line treatment is BCG (Bacillus Calmette-Guérin) immunotherapy, but ongoing BCG shortages and treatment failures leave many patients with limited options. Recurrence is common, often requiring repeat procedures and close monitoring, placing a heavy burden on patients’ health and quality of life.

Purpose

This Phase 2 study evaluates cretostimogene grenadenorepvec, an oncolytic immunotherapy instilled directly into the bladder, across three patient groups: BCG-naïve (Cohort A), BCG-exposed (Cohort B), and BCG-unresponsive (Cohort CX). The primary goal is to determine complete response rates—the proportion of patients with no detectable cancer after treatment. Secondary goals include measuring response durability and assessing safety. This study aims to establish cretostimogene as an effective treatment option regardless of prior BCG history.

Eligibility

• Cohort A: Adults with BCG-naïve, pathologically confirmed high-risk, high-grade NMIBC (CIS ± Ta/T1 disease, or high-grade Ta/T1 without CIS)
• Cohort B: Adults with BCG-exposed high-risk, high-grade NMIBC (same tumor criteria as Cohort A)
• Cohort CX: Adults with BCG-unresponsive high-risk, high-grade NMIBC (same tumor criteria as Cohort A)
• All visible tumor must have been fully resected within 90 days before treatment
• No muscle-invasive or metastatic bladder cancer

Benefits

If you qualify for the study, all study-related medical care and treatment will be provided to you at no cost. You may receive a stipend for your participation in the study.

Send us a message if you are interested in participating in a study.