Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Protara Therapeutics
Study ID
NCT05951179
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TARA-002 — BIOLOGICAL
    All participants will receive 6 weekly instillations of TARA-002 at the established RP2D (First Treatment Period). Participants who are eligible for reinduction after the First Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part of the Second Treatment Period. Participants confirmed to have a complete response after the First Treatment Period will receive 3 additional weekly doses of TARA-002 instillation as maintenance during the Second Treatment Period. All eligible participants will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment Period (maintenance) at Months 6, 9, 12, 15, 18 and 24. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 27 until Month 60.

Study Details

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

Key Dates

Start date
Sep 15, 2023
Status verified
Jan 2026
Primary completion
Oct 31, 2031
Completion
Mar 31, 2032

Study Design

Enrollment
131 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TARA-002
    TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain.

Primary Outcome Measure

Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002 [ Time Frame: Month 3 to Month 60 ]

Central Contacts

Locations (40)

FacilityCityStateZIPSite coordinators
Urology Centers of AlabamaHomewoodAlabama35209
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Mayo ClinicPhoenixArizona85054
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East Valley Urology Center of ArizonaQueen CreekArizona85140
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Arkansas UrologyLittle RockArkansas72211
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Michael Oefelein Clinical TrialsBakersfieldCalifornia93301
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Urology Group of Southern CaliforniaLos AngelesCalifornia90017-
University of California Irvine Medical CenterOrangeCalifornia92697
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Genesis ResearchSan DiegoCalifornia92123-
Genesis Research LLCTorranceCalifornia90505
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Colorado University - AnshutzAuroraColorado80045
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AdventHealth Medical Group Urology of DenverDenverColorado80211
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Advanced UrologyLakewoodColorado80228
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Urology Associates of DenverLone TreeColorado80124
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University of Florida Health JacksonvilleGainesvilleFlorida32611-
Mayo ClinicJacksonvilleFlorida32224
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Comprehensive Urologic CareLake BarringtonIllinois60010
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Southern UrologyLafayetteLouisiana70508
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Ochsner Health LSU - Regional UrologyShreveportLouisiana71105-
Brigham and Women's HospitalBostonMassachusetts02115
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Mayo ClinicRochesterMinnesota55905
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Renown Regional Medical CenterSt LouisMissouri63110
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Specialty Clinic Research of St. LouisSt LouisMissouri63141
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AccuMed Research AssociatesGarden CityNew York11530-
Laura & Isaac Perlmutter Cancer Center - NYU Langone HealthNew YorkNew York10016
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University of Rochester, Department of UrologyRochesterNew York14642
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Montefiore Medical CenterThe BronxNew York10467
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University of ToledoToledoOhio43606-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
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Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572
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Conrad Person ClinicMemphisTennessee38128
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Urology Associates PCNashvilleTennessee37209
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Amarillo Urology ResearchAmarilloTexas79106-
Urology Partners of North TexasArlingtonTexas76017
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Urology Austin, LLCAustinTexas78745
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Clinical Trial NetworkHoustonTexas77074-
Houston Methodist HospitalHoustonTexas77030
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Houston Metro UrologyHoustonTexas77027
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UT Health San AntonioSan AntonioTexas78229
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Virginia UrologyRichmondVirginia23235
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Spokane UrologySpokaneWashington99202
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