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RecruitingInterventionalPhase 2

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

NCT ID: NCT05951179Sponsor: Protara TherapeuticsLast updated: 2026-05-18

Summary

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

Arms & interventions

  • BiologicalTARA-002

    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.

Outcome measures

Primary

  • 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

Secondary

  • Cohort A: Incidence of high-grade Complete Response at any time by subgroup (BCG naive and BCG exposed > 24 months) according to central pathology after treatment with TARA-002

    Time frame: Month 3 to Month 60

  • Cohort A and B: Duration of high-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002

    Time frame: Month 3 to Month 60

  • Cohort A and B: High-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002

    Time frame: Month 3 to Month 60

  • Cohort A and B: Duration of Complete Response (all recurrent bladder cancer, including low grade Ta) after treatment with TARA-002

    Time frame: Month 3 to Month 60

  • Cohort A and B: Complete Response rate (all recurrent bladder cancer, including low grade Ta) at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002

    Time frame: Month 3 to Month 60

  • Cohort A and B: Progression free survival after treatment with TARA-002

    Time frame: 60 months

  • Cohort A and B: Disease-specific progression free survival after treatment with TARA-002

    Time frame: 60 months

  • Cohort A and B: Overall survival after treatment with TARA-002

    Time frame: 60 months

  • Cohort A and B: Disease specific survival after treatment with TARA-002

    Time frame: 60 months

  • Cohort A and B: Time to cystectomy after treatment with TARA-002

    Time frame: 60 months

  • Cohort A and B: Time to recurrence delayed cystectomy after treatment with TARA-002

    Time frame: 60 months

  • Cohort A and B: Time to progression after treatment with TARA-002

    Time frame: 60 months

  • Cohort A and B: Time to disease worsening after treatment with TARA-002

    Time frame: 60 months

  • Cohort A and B: Incidence and severity of AEs, TEAEs, SAEs and TESAEs after treatment with TARA-002

    Time frame: Day 1 to Month 60

  • Cohort A and B: Change from baseline in urine pharmacodynamic biomarker levels (including IL-6, IL-8, IFN-γ, and TNF-α) after treatment with TARA-002

    Time frame: Day 1 to Day 72

  • Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-NMIBC24

    Time frame: Day 1 to Month 24

  • Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-C30

    Time frame: Day 1 to Month 24

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 (Cohort A). Participants with CIS (± Ta/T1) who are BCG unresponsive. 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 locations (40)

Urology Centers of Alabama

Homewood, Alabama, 35209

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Mayo Clinic

Phoenix, Arizona, 85054

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East Valley Urology Center of Arizona

Queen Creek, Arizona, 85140

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Arkansas Urology

Little Rock, Arkansas, 72211

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Michael Oefelein Clinical Trials

Bakersfield, California, 93301

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Urology Group of Southern California

Los Angeles, California, 90017

Terminated

University of California Irvine Medical Center

Orange, California, 92697

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Genesis Research

San Diego, California, 92123

Withdrawn

Genesis Research LLC

Torrance, California, 90505

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Colorado University - Anshutz

Aurora, Colorado, 80045

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AdventHealth Medical Group Urology of Denver

Denver, Colorado, 80211

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Advanced Urology

Lakewood, Colorado, 80228

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Urology Associates of Denver

Lone Tree, Colorado, 80124

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University of Florida Health Jacksonville

Gainesville, Florida, 32611

Withdrawn

Mayo Clinic

Jacksonville, Florida, 32224

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Comprehensive Urologic Care

Lake Barrington, Illinois, 60010

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Southern Urology

Lafayette, Louisiana, 70508

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Ochsner Health LSU - Regional Urology

Shreveport, Louisiana, 71105

Withdrawn

Brigham and Women's Hospital

Boston, Massachusetts, 02115

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Mayo Clinic

Rochester, Minnesota, 55905

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Renown Regional Medical Center

St Louis, Missouri, 63110

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Specialty Clinic Research of St. Louis

St Louis, Missouri, 63141

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AccuMed Research Associates

Garden City, New York, 11530

Terminated

Laura & Isaac Perlmutter Cancer Center - NYU Langone Health

New York, New York, 10016

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University of Rochester, Department of Urology

Rochester, New York, 14642

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Montefiore Medical Center

The Bronx, New York, 10467

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University of Toledo

Toledo, Ohio, 43606

Withdrawn

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

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Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

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Conrad Person Clinic

Memphis, Tennessee, 38128

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Urology Associates PC

Nashville, Tennessee, 37209

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Amarillo Urology Research

Amarillo, Texas, 79106

Withdrawn

Urology Partners of North Texas

Arlington, Texas, 76017

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Urology Austin, LLC

Austin, Texas, 78745

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Houston Metro Urology

Houston, Texas, 77027

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Houston Methodist Hospital

Houston, Texas, 77030

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Clinical Trial Network

Houston, Texas, 77074

Withdrawn

UT Health San Antonio

San Antonio, Texas, 78229

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Virginia Urology

Richmond, Virginia, 23235

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Spokane Urology

Spokane, Washington, 99202

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