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New bladder cancer drug TARA-002 faces chemotherapy in major trial

NCT ID NCT07480356

Disease control Sponsor: Protara Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether a new drug, TARA-002, works better than standard chemotherapy for a type of early-stage bladder cancer. About 284 adults who have not received BCG therapy will be randomly assigned to receive either TARA-002 or chemotherapy directly into the bladder. The study will check if the cancer disappears and how long that lasts, while also monitoring side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 284 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ in situ carcinoma neoplasm non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder (urothelial, transitional cell) cancer Non-muscle invasive bladder cancer with carcinoma in situ Non-muscle invasive bladder carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Arenia - Ivano-Frankivsk

    RECRUITING

    Ivano-Frankivsk, 76018, Ukraine

  • Arensia Kapitanivka - PPDS

    RECRUITING

    Kapitanivka, 08111, Ukraine

  • Arkansas Urology

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • East Valley Urology Center of Arizona

    RECRUITING

    Queen Creek, Arizona, 85140, United States

  • Houston Metro Urology

    RECRUITING

    Houston, Texas, 77027, United States

  • Michael Oefelein Clinical Trials

    RECRUITING

    Bakersfield, California, 93301, United States

  • Renown Regional Medical Center

    RECRUITING

    St Louis, Missouri, 63110, United States

  • START - Carolinas

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Urology Partners of North Texas

    RECRUITING

    Arlington, Texas, 76017, United States

  • Urology of Greater Atlanta - Sandy Springs

    RECRUITING

    Atlanta, Georgia, 30319, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.