Tests TARA-002 given into the bladder for high-grade bladder cancer
Tests TARA-002, given into the bladder, in adults with early high-grade bladder cancer.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Key facts
- Where
- Amarillo, Arlington, Aurora, Austin, Bakersfield, Bloomington, Boston, Cleveland, Denver, Gainesville, Garden City, Homewood, Houston, Jacksonville, Lafayette, Lake Barrington, Lakewood, Little Rock, Lone Tree, Los Angeles, Memphis, Myrtle Beach, Nashville, New York, Orange, Phoenix, Pittsburgh, Plymouth, Queen Creek, Richmond, Rochester, San Antonio, San Diego, Shreveport, Spokane, St Louis, Syracuse, The Bronx, Toledo, and Torrance, United StatesSee the 44 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high-grade non-muscle invasive bladder cancer (carcinoma in situ, with or without Ta/T1 tumours) that is still active. It tests TARA-002 given into the bladder.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- High-grade non-muscle invasive bladder cancer with carcinoma in situ (CIS), with or without Ta/T1 tumours. The disease must be active and confirmed by a central laboratory.
- Earlier treatment
- Cohort A: never had BCG, or had BCG but not into the bladder for at least 24 months before the latest CIS diagnosis. Cohort B: BCG did not work (BCG unresponsive).
Main reasons for not taking part
- Penicillin allergy
- Variant tumour type confirmed by the central laboratory
- Prostate or upper urinary tract involvement
- Cancer spread to lymph nodes or other organs, now or in the past
- Any history of bladder cancer of stage T2 or higher
Read by machine on 9 November 2026.
Where in United States
- Amarillo Urology ResearchAmarillo, United StatesNo longer taking part
- Urology Partners of North TexasArlington, United StatesTaking people
- Colorado University - AnshutzAurora, United StatesTaking people
- Urology Austin, LLCAustin, United StatesTaking people
- Michael Oefelein Clinical TrialsBakersfield, United StatesTaking people
- Minnesota Urology, WoodburyBloomington, United StatesTaking people
- Brigham and Women's HospitalBoston, United StatesTaking people
- Cleveland Clinic Main Campus, ClevelandCleveland, United StatesTaking people
- AdventHealth Medical Group Urology of DenverDenver, United StatesTaking people
- University of Florida Health JacksonvilleGainesville, United StatesNo longer taking part
- AccuMed Research AssociatesGarden City, United StatesNo longer taking part
- Urology Centers of AlabamaHomewood, United StatesTaking people
- Houston Methodist HospitalHouston, United StatesTaking people
- Houston Metro UrologyHouston, United StatesTaking people
- Clinical Trial NetworkHouston, United StatesNo longer taking part
- Mayo ClinicJacksonville, United StatesTaking people
- Southern UrologyLafayette, United StatesTaking people
- Comprehensive Urologic CareLake Barrington, United StatesTaking people
- Advanced UrologyLakewood, United StatesTaking people
- Arkansas UrologyLittle Rock, United StatesTaking people
- Urology Associates of DenverLone Tree, United StatesTaking people
- Urology Group of Southern CaliforniaLos Angeles, United StatesNo longer taking part
- Conrad Person ClinicMemphis, United StatesTaking people
- Carolina Urologic Research CenterMyrtle Beach, United StatesTaking people
- Urology Associates PCNashville, United StatesTaking people
- Laura & Isaac Perlmutter Cancer Center - NYU Langone HealthNew York, United StatesTaking people
- University of California Irvine Medical CenterOrange, United StatesTaking people
- Mayo ClinicPhoenix, United StatesTaking people
- University of Pittsburgh Medical CenterPittsburgh, United StatesTaking people
- Greater Boston Urology, LLCPlymouth, United StatesTaking people
- East Valley Urology Center of ArizonaQueen Creek, United StatesTaking people
- Virginia UrologyRichmond, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- University of Rochester, Department of UrologyRochester, United StatesTaking people
- UT Health San AntonioSan Antonio, United StatesTaking people
- Genesis ResearchSan Diego, United StatesNo longer taking part
- Ochsner Health LSU - Regional UrologyShreveport, United StatesNo longer taking part
- Spokane UrologySpokane, United StatesTaking people
- Renown Regional Medical CenterSt Louis, United StatesTaking people
- Specialty Clinic Research of St. LouisSt Louis, United StatesTaking people
- Associated Medical Professionals of NY, PLLCSyracuse, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- University of ToledoToledo, United StatesNo longer taking part
- Genesis Research LLCTorrance, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Protara Therapeutics
- Trial code
- NCT05951179
- Record updated
- 24 August 2026
- Original description
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).Read full original descriptionShow less
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
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).
The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).
This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF.
Participants will be enrolled into one of 2 cohorts:
Cohort A:
* Participants with CIS (± Ta/T1) who are BCG naive, or * Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis
Cohort B:
* Participants who are BCG unresponsive
Inclusion: 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: 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; Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory; Central confirmed variant histology.