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Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

Studying safety and effects of a treatment for high-risk bladder cancer.

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18 years and older
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Phase 2
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is testing a treatment for high-risk non-muscle-invasive bladder cancer (NMIBC). NMIBC means the cancer is in the bladder but hasn't spread to the muscle. The study is divided into three groups, or cohorts. In **Cohort A**, up to 125 people who haven't had a specific treatment called Bacillus Calmette-Guerin (BCG) will be tested. **Cohort B** will include 150 people who have had BCG treatment before. **Cohort CX** will have 50 people who didn't respond to BCG or had it before. Everyone in the study will receive a medicine called cretostimogene, and some in Cohort CX will also get gemcitabine. Treatments are given weekly for 6 weeks, then less often if the disease doesn't come back. Doctors will check the bladder every few months for 4 years.

  • Participation lasts up to 4 years with regular check-ups.
  • Participants must have had specific types of bladder cancer confirmed by doctors.
  • Women who are pregnant or breastfeeding cannot join the study.
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Study details
    High-Risk Non-Muscle-Invasive Bladder Cancer

NCT06567743

CG Oncology, Inc.

10 May 2025

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