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NCT07480356 · ClinicalTrials.gov registry record · Phase 3
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 study, sponsored by Protara Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 284
- Enrollment target
NCT07480356: Recruiting Phase 3 study, sponsored by Protara Therapeutics.
NCT07480356 is a Phase 3 study that is actively recruiting participants, run by Protara Therapeutics. The registered enrollment target is 284 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07480356, a Phase 3 study, is actively recruiting participants, sponsored by Protara Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 284 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy determined by cystoscopy, urine cytology, and bladder biopsy (if applicable)
Interventions
- DRUG TARA-002
- DRUG Investigator's Choice of Intravesical Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2026-05-29 |
| Est. Completion | 2032-11 |
| Phase | Phase 3 |
What NCT07480356 shows while recruiting
NCT07480356 is an interventional study that assigns participants to a tested intervention. The registered 284 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which TARA-002 is the first listed.
NCT07480356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07480356 about?
NCT07480356 is a clinical study titled "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". 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 is the current status of trial NCT07480356?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 284 participants. The study started on 2026-05-29. Estimated completion is 2032-11.
What interventions are being tested in trial NCT07480356?
The interventions under investigation include: TARA-002 (DRUG), Investigator's Choice of Intravesical Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT07480356?
This trial is sponsored by Protara Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07480356's enrollment target sits among peer trials
284 1189th of 2000 higher than 807 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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