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Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Sponsor: Protara Therapeutics
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
131
Start Date
2023-09-15
Completion Date
2030-08
Last Updated
2026-01-27
Healthy Volunteers
No
Conditions
Interventions
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, and 18. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 21 until Month 60.
Locations (61)
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
Mayo Clinic
Rochester, Minnesota, United States
Washington University
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
University of Rochester, Department of Urology
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, 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
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
Fuji City General Hospital
Nova Lima, Minas Gerais, Brazil
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
Komaki City Hospital
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
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Japanese Red Cross Osaka Hospital
Osaka, Osaka, Japan
Tokyo University Medical Center Sakura Hospital
Fuji-shi, Shizuoka, Japan
Arensia Kapitanivka - PPDS
Kapitanivka, Ukraine