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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