RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Protara Therapeutics • ClinicalTrials.gov ID: NCT05951179

Registry updated: 2026-08-24

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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). 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

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.

Eligibility criteria

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

Conditions

Non-muscle Invasive Bladder Cancer

Locations

Urology Centers of Alabama — Homewood, Alabama, United States
Mayo Clinic — Phoenix, Arizona, United States
East Valley Urology Center of Arizona — Queen Creek, Arizona, United States
Arkansas Urology — Little Rock, Arkansas, United States
Michael Oefelein Clinical Trials — Bakersfield, California, United States
Urology Group of Southern California — Los Angeles, California, United States
University of California Irvine Medical Center — Orange, California, United States
Genesis Research — San Diego, California, United States
Genesis Research LLC — Torrance, California, United States
Colorado University - Anshutz — Aurora, Colorado, United States
AdventHealth Medical Group Urology of Denver — Denver, Colorado, United States
Advanced Urology — Lakewood, Colorado, United States
Urology Associates of Denver — Lone Tree, Colorado, United States
University of Florida Health Jacksonville — Gainesville, Florida, United States
Mayo Clinic — Jacksonville, Florida, United States
Comprehensive Urologic Care — Lake Barrington, Illinois, United States
Southern Urology — Lafayette, Louisiana, United States
Ochsner Health LSU - Regional Urology — Shreveport, Louisiana, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Greater Boston Urology, LLC — Plymouth, Massachusetts, United States
Minnesota Urology, Woodbury — Bloomington, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
Renown Regional Medical Center — St Louis, Missouri, United States
Specialty Clinic Research of St. Louis — St Louis, Missouri, United States
AccuMed Research Associates — Garden City, New York, United States
Laura & Isaac Perlmutter Cancer Center - NYU Langone Health — New York, New York, United States
University of Rochester, Department of Urology — Rochester, New York, United States
Associated Medical Professionals of NY, PLLC — Syracuse, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Cleveland Clinic Main Campus, Cleveland — Cleveland, Ohio, United States
University of Toledo — Toledo, Ohio, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
Conrad Person Clinic — Memphis, Tennessee, United States
Urology Associates PC — Nashville, Tennessee, United States
Amarillo Urology Research — Amarillo, Texas, United States
Urology Partners of North Texas — Arlington, Texas, United States
Urology Austin, LLC — Austin, Texas, United States
Houston Metro Urology — Houston, Texas, United States
Houston Methodist Hospital — Houston, Texas, United States
Clinical Trial Network — Houston, Texas, United States
UT Health San Antonio — San Antonio, Texas, United States
Virginia Urology — Richmond, Virginia, United States
Spokane Urology — Spokane, Washington, United States
Hospital Italiano de Buenos Aires (HIBA) — Buenos Aires, Argentina
Hospital Britanico de Buenos Aires — Buenos Aires, Argentina
Centro Argentino de Urologia — CABA, Argentina
Hospital Sirio Libanes — CABA, Argentina
Centro Urologico Profesor Bengio SA — Córdoba, Argentina
CEMAIC — Córdoba, Argentina
Clinica Privada Independencia — Munro, Argentina
Kyushu University Hospital — Nova Lima, Minas Gerais, Brazil
Office of Lucas Nougeria MA — Nova Lima, Minas Gerais, Brazil
Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
Nucleo de Pesquisa Clinica do Rio Grande so Sul — Porto Alegre, Rio Grande do Sul, Brazil
Centro de Urologia Avancada — Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas da UNICAMP — Campinas, São Paulo, Brazil
Instituto Dor de Pesquisa e Ensino — Jardim Paulista, São Paulo, Brazil
Faculdade de Medicina ABC-CEPHO — Santo André, São Paulo, Brazil
Exdeo Clinical Research Inc — Abbotsford British Columbia, British Columbia, Canada
Jonathan Giddes Medicine Professional Corporation — Brampton, Ontario, Canada
Sunnybrook Research Institute — Toronto, Ontario, Canada
UHN Princess Margaret Cancer Centre Princess Margaret Hospital — Toronto, Ontario, Canada
The Research Institute of the McGill University Health Centre — Montreal, Quebec, Canada
Komaki City Hospital — Komaki-shi, Aichi-ken, Japan
Japanese Red Cross Aichi Medical Center Nayoya Daiichi — Nagoya, Aichi-ken, Japan
Funabashi Municipal Medical Center — Funabashi-shi, Chiba, Japan
Fuji City General Hospital — Sakura-shi, Chiba, Japan
Kyushu University Hospital — Fukuoka, Fukuoka, Japan
Hyogo Prefectural Amagasaki General Medical Center — Amagasaki-shi, Hyōgo, Japan
Hitachi General Hospital — Hitachi-shi, Ibaraki, Japan
Yokohama Municipal Citizen's Hospital — Yokohama, Kanagawa, Japan
Niigata Cancer Center Hospital — Niigata, Niigata, Japan
Japanese Red Cross Osaka Hospital — Osaka, Osaka, Japan
Toho University Medical Center Sakura Hospital — Fuji-shi, Shizuoka, Japan
Toyama University Hospital — Toyama, Toyama, Japan
Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Kanagawa, Taiwan
Arensia Kapitanivka - PPDS — Kapitanivka, Ukraine

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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