drugset / Trial / NCT07480356

Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer

NCT07480356

Phase 3 Recruiting 284 enrolled Protara Therapeutics
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older. The main questions it aims to answer are: * Can the study drug help participants with this type of cancer? * Is the study drug safe? * What are the side effects of the study drug? Researchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.

Timeline

Start
2026-05-29
Primary completion
2028-04
Completion
2032-11

Drugs

EvaluationDrugModalityDoseRoute
Subject OK-432 Unknown Other