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.
Male or female participants 18 years of age or older at the time of signing informed consent
Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis, or participants who received ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis
Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
Central confirmed variant histology
Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)
Protara Therapeutics
Lead sponsor