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

NCT05951179 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TARA-002-101-Ph2
• Study Type: interventional
• Target: 131
• Locations: 6 countries
• Sites: 61

Brief 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

Conditions

Non-muscle Invasive Bladder Cancer

Keywords

Non-muscle invasive bladder Cancer; bladder cancer; high grade Ta; high grade NMIBC; carcinoma in situ

Outcome Measures

Primary Outcomes (2)

• Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002

  Month 3 to Month 60

• 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

  Month 3 to Month 60

Secondary Outcomes (16)

• 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

  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

  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

  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

  Month 3 to Month 60

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

  60 months

Study Arms (1)

TARA-002

EXPERIMENTAL

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

Biological: TARA-002

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, and 18. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 21 until Month 60.

TARA-002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Protara Therapeutics: lead

Study Sites (61)

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

RECRUITING

Mayo Clinic

Phoenix, Arizona, 85054, United States

RECRUITING

East Valley Urology Center of Arizona

Queen Creek, Arizona, 85140, United States

RECRUITING

Arkansas Urology

Little Rock, Arkansas, 72211, United States

RECRUITING

Michael Oefelein Clinical Trials

Bakersfield, California, 93301, United States

RECRUITING

Urology Group of Southern California

Los Angeles, California, 90017, United States

RECRUITING

University of California Irvine Medical Center

Orange, California, 92697, United States

RECRUITING

Genesis Research

San Diego, California, 92123, United States

WITHDRAWN

Genesis Research LLC

Torrance, California, 90505, United States

RECRUITING

Colorado University - Anshutz

Aurora, Colorado, 80045, United States

RECRUITING

AdventHealth Medical Group Urology of Denver

Denver, Colorado, 80211, United States

RECRUITING

Advanced Urology

Lakewood, Colorado, 80228, United States

RECRUITING

Urology Associates of Denver

Lone Tree, Colorado, 80124, United States

RECRUITING

University of Florida Health Jacksonville

Gainesville, Florida, 32611, United States

WITHDRAWN

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Comprehensive Urologic Care

Lake Barrington, Illinois, 60010, United States

RECRUITING

Southern Urology

Lafayette, Louisiana, 70508, United States

RECRUITING

Ochsner Health LSU - Regional Urology

Shreveport, Louisiana, 71105, United States

WITHDRAWN

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Specialty Clinic Research of St. Louis

St Louis, Missouri, 63141, United States

RECRUITING

AccuMed Research Associates

Garden City, New York, 11530, United States

TERMINATED

University of Rochester, Department of Urology

Rochester, New York, 14642, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

University of Toledo

Toledo, Ohio, 43606, United States

WITHDRAWN

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Conrad Person Clinic

Memphis, Tennessee, 38128, United States

RECRUITING

Urology Associates PC

Nashville, Tennessee, 37209, United States

RECRUITING

Amarillo Urology Research

Amarillo, Texas, 79106, United States

WITHDRAWN

Urology Partners of North Texas

Arlington, Texas, 76017, United States

RECRUITING

Urology Austin, LLC

Austin, Texas, 78745, United States

RECRUITING

Houston Metro Urology

Houston, Texas, 77027, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Clinical Trial Network

Houston, Texas, 77074, United States

WITHDRAWN

UT Health San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Virginia Urology

Richmond, Virginia, 23235, United States

RECRUITING

Centro Argentino de Urologia

CABA, C1419, Argentina

RECRUITING

Hospital Sirio Libanes

CABA, C1419, Argentina

RECRUITING

Centro Urologico Profesor Bengio SA

Córdoba, X5000KPH, Argentina

RECRUITING

CEMAIC

Córdoba, X5088, Argentina

RECRUITING

Clinica Privada Independencia

Munro, 1605, Argentina

RECRUITING

Fuji City General Hospital

Nova Lima, Minas Gerais, 34006-059, Brazil

RECRUITING

Kyushu University Hospital

Nova Lima, Minas Gerais, 34006-059, Brazil

RECRUITING

Office of Lucas Nougeria MA

Nova Lima, Minas Gerais, 34006-059, Brazil

RECRUITING

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-070, Brazil

RECRUITING

Nucleo de Pesquisa Clinica do Rio Grande so Sul

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

RECRUITING

Centro de Urologia Avancada

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

RECRUITING

Komaki City Hospital

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

RECRUITING

Hospital de Clinicas da UNICAMP

Campinas, São Paulo, 13083-970, Brazil

RECRUITING

Instituto Dor de Pesquisa e Ensino

Jardim Paulista, São Paulo, 01401-002, Brazil

RECRUITING

Faculdade de Medicina ABC-CEPHO

Santo André, São Paulo, 09060-650, Brazil

RECRUITING

Exdeo Clinical Research Inc

Abbotsford British Columbia, British Columbia, V2T 1X8, Canada

RECRUITING

Jonathan Giddes Medicine Professional Corporation

Brampton, Ontario, L6T 4S5, Canada

WITHDRAWN

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

WITHDRAWN

UHN Princess Margaret Cancer Centre Princess Margaret Hospital

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

Niigata Cancer Center Hospital

Niigata, Niigata, 961-8566, Japan

RECRUITING

Japanese Red Cross Osaka Hospital

Osaka, Osaka, 543-855, Japan

RECRUITING

Tokyo University Medical Center Sakura Hospital

Fuji-shi, Shizuoka, 417-8567, Japan

RECRUITING

Arensia Kapitanivka - PPDS

Kapitanivka, 08111, Ukraine

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms; Carcinoma in Situ

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Chief Scientific Operations Officer

  Protara Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Chief Scientific Operations Officer

CONTACT

16468440337; clinicaltrials@protaratx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: June 29, 2023
• First Posted: July 18, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (10); CA (4); JP (3); US (38); UA (1); AR (5)