Recruiting
Phase 3

TARA-002 vs. Chemotherapy

Sponsor:

Protara Therapeutics

Code:

NCT07480356

Conditions

Bladder (Urothelial, Transitional Cell) Cancer

Non-Muscle Invasive Bladder Carcinoma

Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TARA-002

Investigator's Choice of Intravesical Chemotherapy

Study Details

Brief 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.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer

Non-Muscle Invasive Bladder Carcinoma

Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

Study ID

NCT07480356

Start date

May 29, 2026

Status verified date

Jun, 2026

Completion date

Nov, 2032

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

284 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TARA-002 (Arm A)

active comparator: Investigator's choice of intravesical chemotherapy

Interventions

TARA-002

Participants will receive 6 weekly instillations of TARA-002. Participants confirmed to have a CR at Week 12 will enter the maintenance treatment period and will receive 3 additional weekly instillations of TARA-002 every 3 months up to Month 19, and then 3 weekly doses at Month 25. Participants who are eligible for reinduction at Week 12 will receive 6 additional weekly instillations of TARA-002. Participants who undergo reinduction and are confirmed to have a CR at Week 24 will enter the maintenance regimen treatment period and will receive 3 weekly instillations of TARA-002 every 3 months up to Month 19, and then 3 weekly doses at Month 25.

Investigator's Choice of Intravesical Chemotherapy

Participants will receive 6 weekly instillations of Investigator's choice of intravesical chemotherapy. Participants confirmed to have a CR at Week 12 will enter the maintenance regimen treatment period and will receive one intravesical instillation of Investigator's choice of intravesical chemotherapy every 1 month up to Month 25.

Primary outcome measure

  • Incidence of high-grade complete response [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Chief R&D Officer

16468440337clinicaltrials@protaratx.com

Locations

East Valley Urology Center of Arizona

Recruiting

Queen Creek, Arizona, United States, 85140

Arkansas Urology

Recruiting

Little Rock, Arkansas, United States, 72211

Michael Oefelein Clinical Trials

Recruiting

Bakersfield, California, United States, 93301

Urology of Greater Atlanta - Sandy Springs

Recruiting

Atlanta, Georgia, United States, 30319

Renown Regional Medical Center

Recruiting

St Louis, Missouri, United States, 63110

START - Carolinas

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Urology Partners of North Texas

Recruiting

Arlington, Texas, United States, 76017

Houston Metro Urology

Recruiting

Houston, Texas, United States, 77027

More Information

Sponsor

Protara Therapeutics

Last update posted

Aug 21, 2026

Last verified

Jun, 2026

Keywords

  • BCG-naive
  • Non-muscle invasive bladder Cancer
  • bladder cancer
  • carcinoma in situ

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Protara Therapeutics on 2026-08-21.