RecruitingPhase IIEN originalBladder cancer

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Osoby w wieku 18 lat i starsze.
  • Osoby, które wyraziły zgodę na udział w badaniu.
  • Osoby z potwierdzonym, agresywnym rakiem pęcherza moczowego, który nie nacieka mięśni.
  • Osoby, które wcześniej nie były leczone lekiem BCG lub ostatnie leczenie BCG otrzymały ponad 24 miesiące temu.
  • Osoby, które nie zareagowały na wcześniejsze leczenie BCG.

✗ Disqualifies

  • Alergia na penicylinę.
  • Inne rodzaje raka pęcherza niż ten badany.
  • Rak, który rozprzestrzenił się do węzłów chłonnych lub innych części ciała.
  • Rak pęcherza moczowego, który w przeszłości naciekał mięśnie.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 30, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (71)

Urology Centers of Alabama

Homewood, United States

Mayo Clinic

Phoenix, United States

East Valley Urology Center of Arizona

Queen Creek, United States

Arkansas Urology

Little Rock, United States

Michael Oefelein Clinical Trials

Bakersfield, United States

Urology Group of Southern California

Los Angeles, United States

University of California Irvine Medical Center

Orange, United States

Genesis Research

San Diego, United States

Genesis Research LLC

Torrance, United States

Colorado University - Anshutz

Aurora, United States

AdventHealth Medical Group Urology of Denver

Denver, United States

Advanced Urology

Lakewood, United States

Urology Associates of Denver

Lone Tree, United States

University of Florida Health Jacksonville

Gainesville, United States

Mayo Clinic

Jacksonville, United States

Comprehensive Urologic Care

Lake Barrington, United States

Southern Urology

Lafayette, United States

Ochsner Health LSU - Regional Urology

Shreveport, United States

Brigham and Women's Hospital

Boston, United States

Minnesota Urology, Woodbury

Bloomington, United States

Mayo Clinic

Rochester, United States

Renown Regional Medical Center

St Louis, United States

Specialty Clinic Research of St. Louis

St Louis, United States

AccuMed Research Associates

Garden City, United States

Laura & Isaac Perlmutter Cancer Center - NYU Langone Health

New York, United States

University of Rochester, Department of Urology

Rochester, United States

Montefiore Medical Center

The Bronx, United States

University of Toledo

Toledo, United States

University of Pittsburgh Medical Center

Pittsburgh, United States

Carolina Urologic Research Center

Myrtle Beach, United States

Conrad Person Clinic

Memphis, United States

Urology Associates PC

Nashville, United States

Amarillo Urology Research

Amarillo, United States

Urology Partners of North Texas

Arlington, United States

Urology Austin, LLC

Austin, United States

Houston Metro Urology

Houston, United States

Houston Methodist Hospital

Houston, United States

Clinical Trial Network

Houston, United States

UT Health San Antonio

San Antonio, United States

Virginia Urology

Richmond, United States

Spokane Urology

Spokane, 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, Brazil

Office of Lucas Nougeria MA

Nova Lima, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Nucleo de Pesquisa Clinica do Rio Grande so Sul

Porto Alegre, Brazil

Centro de Urologia Avancada

Porto Alegre, Brazil

Hospital de Clinicas da UNICAMP

Campinas, Brazil

Instituto Dor de Pesquisa e Ensino

Jardim Paulista, Brazil

Faculdade de Medicina ABC-CEPHO

Santo André, Brazil

Exdeo Clinical Research Inc

Abbotsford British Columbia, Canada

Jonathan Giddes Medicine Professional Corporation

Brampton, Canada

Sunnybrook Research Institute

Toronto, Canada

UHN Princess Margaret Cancer Centre Princess Margaret Hospital

Toronto, Canada

Komaki City Hospital

Komaki-shi, Japan

Japanese Red Cross Aichi Medical Center Nayoya Daiichi

Nagoya, Japan

Fuji City General Hospital

Sakura-shi, Japan

Kyushu University Hospital

Fukuoka, Japan

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki-shi, Japan

Hitachi General Hospital

Hitachi-shi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Japanese Red Cross Osaka Hospital

Osaka, Japan

Toho University Medical Center Sakura Hospital

Fuji-shi, Japan

Toyama University Hospital

Toyama, Japan

Arensia Kapitanivka - PPDS

Kapitanivka, Ukraine

Trial contact

Chief Scientific Operations Officer

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.

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