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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

A Phase 3, Randomized Study to Evaluate the 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

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history

For more information on eligibility criteria, please contact the Sponsor.

About the study

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.

What is being tested

• TARA-002 (drug)
• Investigator's Choice of Intravesical Chemotherapy (drug)

Sponsor: Protara Therapeutics · Participants: 284 · Started: May 29, 2026

Contact the study team

• Chief R&D Officer · Phone: 16468440337

Official record on ClinicalTrials.gov — NCT07480356

Locations in the U.S.

Conditions

• Cancer (all types)
• Non-Muscle Invasive Bladder Cancer
• Bladder Cancer
• Carcinoma in Situ

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.