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Investigating TARA-002 for treating high-grade bladder cancer

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer

Phase 2 Interventional Protara Therapeutics · NCT05951179

This study is testing a new treatment called TARA-002 to see if it can help adults with high-grade bladder cancer feel better and fight the disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment131 (estimated)
Ages18 Years and up
SexAll
SponsorProtara Therapeutics Industry-sponsored
Locations61 sites (Homewood, Alabama and 60 other locations)
Trial IDNCT05951179 on ClinicalTrials.gov

What this trial studies

This Phase 2 study evaluates the safety and anti-tumor activity of TARA-002, administered through intravesical instillation, in adults with high-grade non-muscle invasive bladder cancer (NMIBC). Participants are divided into two cohorts: one for those who are BCG naive or have not received BCG for at least 24 months, and another for those with persistent or recurrent disease who are BCG unresponsive. The study aims to build on findings from a previous Phase 1a dose-finding study to determine the optimal dose and efficacy of TARA-002.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed high-grade non-muscle invasive bladder cancer who meet specific cohort criteria regarding previous BCG treatment.

Not a fit: Patients with predominant adenocarcinoma, squamous cell carcinoma, or other histological variants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with high-grade non-muscle invasive bladder cancer.

How similar studies have performed: Other studies have shown promise with similar intravesical therapies, but this specific approach with TARA-002 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 (Cohort A). Participants with CIS (± Ta/T1) who are BCG unresponsive.

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

Where this trial is running

Homewood, Alabama and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-muscle Invasive Bladder CancerNon-muscle invasive bladder Cancerbladder cancerhigh grade Tahigh grade NMIBCcarcinoma in situ
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.