Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer (ADVANCED-2)

May 14, 2026 updated by: Protara Therapeutics

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

131

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • CABA, Argentina, C1419
        • Recruiting
        • Centro Argentino de Urologia
        • Contact:
          • Use Central Contact
      • CABA, Argentina, C1419
        • Recruiting
        • Hospital Sirio Libanes
        • Contact:
          • Use Central Contact
      • Córdoba, Argentina, X5000KPH
        • Recruiting
        • Centro Urologico Profesor Bengio SA
        • Contact:
          • Use Central Contact
      • Córdoba, Argentina, X5088
        • Recruiting
        • CEMAIC
        • Contact:
          • Use Central Contact
      • Munro, Argentina, 1605
        • Recruiting
        • Clinica Privada Independencia
        • Contact:
          • Use Central Contact
  • Brazil
    • Minas Gerais
      • Nova Lima, Minas Gerais, Brazil, 34006-059
        • Recruiting
        • Kyushu University Hospital
        • Contact:
          • Use Central Contact
      • Nova Lima, Minas Gerais, Brazil, 34006-059
        • Recruiting
        • Office of Lucas Nougeria MA
        • Contact:
          • Use Central Contact
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-070
        • Recruiting
        • Santa Casa de Misericordia de Porto Alegre
        • Contact:
          • Use Central Contact
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
        • Recruiting
        • Nucleo de Pesquisa Clinica do Rio Grande so Sul
        • Contact:
          • Use Central Contact
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Recruiting
        • Centro de Urologia Avancada
        • Contact:
          • Use Central Contact
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-970
        • Recruiting
        • Hospital de Clínicas da Unicamp
        • Contact:
          • Use Central Contact
      • Jardim Paulista, São Paulo, Brazil, 01401-002
        • Recruiting
        • Instituto Dor de Pesquisa E Ensino
        • Contact:
          • Use Central Contact
      • Santo André, São Paulo, Brazil, 09060-650
        • Recruiting
        • Faculdade de Medicina ABC-CEPHO
        • Contact:
          • Use Central Contact
  • Canada
    • British Columbia
      • Abbotsford British Columbia, British Columbia, Canada, V2T 1X8
        • Terminated
        • Exdeo Clinical Research Inc
    • Ontario
      • Brampton, Ontario, Canada, L6T 4S5
        • Withdrawn
        • Jonathan Giddes Medicine Professional Corporation
      • Toronto, Ontario, Canada, M4N 3M5
        • Withdrawn
        • Sunnybrook Research Institute
      • Toronto, Ontario, Canada, M5G 1Z5
        • Recruiting
        • UHN Princess Margaret Cancer Centre Princess Margaret Hospital
  • Japan
    • Aichi-ken
      • Komaki-shi, Aichi-ken, Japan, 485-0044
        • Recruiting
        • Komaki City Hospital
        • Contact:
          • Use Central Contact
      • Nagoya, Aichi-ken, Japan, 435-8511
        • Recruiting
        • Japanese Red Cross Aichi Medical Center Nayoya Daiichi
        • Contact:
          • Use Central Contact
    • Chiba
      • Sakura-shi, Chiba, Japan, 285-8741
        • Recruiting
        • Fuji City General Hospital
        • Contact:
          • Use Central Contact
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
          • Use Central Contact
    • Ibaraki
      • Hitachi-shi, Ibaraki, Japan, 317-0077
        • Recruiting
        • Hitachi General Hospital
        • Contact:
          • Use Central Contact
    • Niigata
      • Niigata, Niigata, Japan, 961-8566
        • Recruiting
        • Niigata Cancer Center Hospital
        • Contact:
          • Use Central Contact
    • Osaka
      • Osaka, Osaka, Japan, 543-855
        • Recruiting
        • Japanese Red Cross Osaka Hospital
        • Contact:
          • Use Central Contact
    • Shizuoka
      • Fuji-shi, Shizuoka, Japan, 417-8567
        • Recruiting
        • Toho University Medical Center Sakura Hospital
        • Contact:
          • Use Central Contact
  • Ukraine
      • Kapitanivka, Ukraine, 08111
        • Recruiting
        • Arensia Kapitanivka - PPDS
        • Contact:
          • Use Central Contact
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Recruiting
        • Urology Centers Of Alabama
        • Contact:
          • Use Central Contact
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Use Central Contact
      • Queen Creek, Arizona, United States, 85140
        • Recruiting
        • East Valley Urology Center of Arizona
        • Contact:
          • Use Central Contact
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Arkansas Urology
        • Contact:
          • Use Central Contact
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • Michael Oefelein Clinical Trials
        • Contact:
          • Use Central Contact
      • Los Angeles, California, United States, 90017
        • Terminated
        • Urology Group of Southern California
      • Orange, California, United States, 92697
        • Recruiting
        • University of California Irvine Medical Center
        • Contact:
          • Use Central Contact
      • San Diego, California, United States, 92123
        • Withdrawn
        • Genesis Research
      • Torrance, California, United States, 90505
        • Recruiting
        • Genesis Research LLC
        • Contact:
          • Use Central Contact
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Colorado University - Anshutz
        • Contact:
          • Use Central Contact
      • Denver, Colorado, United States, 80211
        • Recruiting
        • AdventHealth Medical Group Urology of Denver
        • Contact:
          • Use Central Contact
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Advanced Urology
        • Contact:
          • Use Central Contact
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Urology Associates of Denver
        • Contact:
          • Use Central Contact
    • Florida
      • Gainesville, Florida, United States, 32611
        • Withdrawn
        • University of Florida Health Jacksonville
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Use Central Contact
    • Illinois
      • Lake Barrington, Illinois, United States, 60010
        • Recruiting
        • Comprehensive Urologic Care
        • Contact:
          • Use Central Contact
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Recruiting
        • Southern Urology
        • Contact:
          • Use Central Contact
      • Shreveport, Louisiana, United States, 71105
        • Withdrawn
        • Ochsner Health LSU - Regional Urology
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
          • Use Central Contact
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Use Central Contact
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Specialty Clinic Research of St. Louis
        • Contact:
          • Use Central Contact
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
          • Use Central Contact
    • New York
      • Garden City, New York, United States, 11530
        • Terminated
        • AccuMed Research Associates
      • New York, New York, United States, 10016
        • Recruiting
        • Laura & Isaac Perlmutter Cancer Center - NYU Langone Health
        • Contact:
          • Use Central Contact
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester, Department of Urology
        • Contact:
          • Use Central Contact
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
          • Use Central Contact
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Withdrawn
        • University of Toledo
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
          • Use Central Contact
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center
        • Contact:
          • Use Central Contact
    • Tennessee
      • Memphis, Tennessee, United States, 38128
        • Recruiting
        • Conrad Person Clinic
        • Contact:
          • Use Central Contact
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates PC
        • Contact:
          • Use Central Contact
    • Texas
      • Amarillo, Texas, United States, 79106
        • Withdrawn
        • Amarillo Urology Research
      • Arlington, Texas, United States, 76017
        • Recruiting
        • Urology Partners of North Texas
        • Contact:
          • Use Central Contact
      • Austin, Texas, United States, 78745
        • Recruiting
        • Urology Austin, LLC
        • Contact:
          • Use Central Contact
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
          • Use Central Contact
      • Houston, Texas, United States, 77027
        • Recruiting
        • Houston Metro Urology
        • Contact:
          • Use Central Contact
      • Houston, Texas, United States, 77074
        • Withdrawn
        • Clinical Trial Network
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health San Antonio
        • Contact:
          • Use Central Contact
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • Virginia Urology
        • Contact:
          • Use Central Contact
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Spokane Urology
        • Contact:
          • Use Central Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TARA-002
TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain.
Biological: TARA-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Month 3 to Month 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Month 3 to Month 60
Cohort A and B: Progression free survival after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Disease-specific progression free survival after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Overall survival after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Disease specific survival after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Time to cystectomy after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Time to recurrence delayed cystectomy after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Time to progression after treatment with TARA-002
Time Frame: 60 months
60 months
Cohort A and B: Time to disease worsening after treatment with TARA-002
Time Frame: 60 months
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
AE = adverse event; TEAE = treatment emergent adverse event; SAE = serious adverse event; TESAE = treatment emergent serious adverse event
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
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
EORTC = European Organization for Research and Treatment of Cancer; QLQ-NMIBC24 = Questionnaire for Patients with NMIBC
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
EORTC = European Organization for Research and Treatment of Cancer; QLQ-C30 = Questionnaire for Patients with Cancer
Day 1 to Month 24
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
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
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
Month 3 to Month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protara Therapeutics

Investigators

  • Study Director: Chief Scientific Operations Officer, Protara Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Estimated)

October 1, 2031

Study Completion (Estimated)

March 1, 2032

Study Registration Dates

First Submitted

June 29, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARA-002-101-Ph2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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