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
Status: Recruiting
Location: See all (61) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Urology Centers of Alabama
RECRUITING
Homewood
Arkansas
Arkansas Urology
RECRUITING
Little Rock
Arizona
Mayo Clinic
RECRUITING
Phoenix
East Valley Urology Center of Arizona
RECRUITING
Queen Creek
California
Michael Oefelein Clinical Trials
RECRUITING
Bakersfield
Urology Group of Southern California
RECRUITING
Los Angeles
University of California Irvine Medical Center
RECRUITING
Orange
Genesis Research
WITHDRAWN
San Diego
Genesis Research LLC
RECRUITING
Torrance
Colorado
Colorado University - Anshutz
RECRUITING
Aurora
AdventHealth Medical Group Urology of Denver
RECRUITING
Denver
Advanced Urology
RECRUITING
Lakewood
Urology Associates of Denver
RECRUITING
Lone Tree
Florida
University of Florida Health Jacksonville
WITHDRAWN
Gainesville
Mayo Clinic
RECRUITING
Jacksonville
Illinois
Comprehensive Urologic Care
RECRUITING
Lake Barrington
Louisiana
Southern Urology
RECRUITING
Lafayette
Ochsner Health LSU - Regional Urology
WITHDRAWN
Shreveport
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
Specialty Clinic Research of St. Louis
RECRUITING
St Louis
Washington University
RECRUITING
St Louis
New York
AccuMed Research Associates
TERMINATED
Garden City
University of Rochester, Department of Urology
RECRUITING
Rochester
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
University of Toledo
WITHDRAWN
Toledo
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
South Carolina
Carolina Urologic Research Center
RECRUITING
Myrtle Beach
Tennessee
Conrad Person Clinic
RECRUITING
Memphis
Urology Associates PC
RECRUITING
Nashville
Texas
Amarillo Urology Research
WITHDRAWN
Amarillo
Urology Partners of North Texas
RECRUITING
Arlington
Urology Austin, LLC
RECRUITING
Austin
Clinical Trial Network
WITHDRAWN
Houston
Houston Methodist Hospital
RECRUITING
Houston
Houston Metro Urology
RECRUITING
Houston
UT Health San Antonio
RECRUITING
San Antonio
Virginia
Virginia Urology
RECRUITING
Richmond
Other Locations
Argentina
Centro Argentino de Urologia
RECRUITING
Caba
Hospital Sirio Libanes
RECRUITING
Caba
CEMAIC
RECRUITING
Córdoba
Centro Urologico Profesor Bengio SA
RECRUITING
Córdoba
Clinica Privada Independencia
RECRUITING
Munro
Brazil
Hospital de Clinicas da UNICAMP
RECRUITING
Campinas
Instituto Dor de Pesquisa e Ensino
RECRUITING
Jardim Paulista
Fuji City General Hospital
RECRUITING
Nova Lima
Kyushu University Hospital
RECRUITING
Nova Lima
Office of Lucas Nougeria MA
RECRUITING
Nova Lima
Centro de Urologia Avancada
RECRUITING
Porto Alegre
Komaki City Hospital
RECRUITING
Porto Alegre
Nucleo de Pesquisa Clinica do Rio Grande so Sul
RECRUITING
Porto Alegre
Santa Casa de Misericordia de Porto Alegre
RECRUITING
Porto Alegre
Faculdade de Medicina ABC-CEPHO
RECRUITING
Santo André
Canada
Exdeo Clinical Research Inc
RECRUITING
Abbotsford British Columbia
Jonathan Giddes Medicine Professional Corporation
WITHDRAWN
Brampton
Sunnybrook Research Institute
WITHDRAWN
Toronto
UHN Princess Margaret Cancer Centre Princess Margaret Hospital
RECRUITING
Toronto
Japan
Tokyo University Medical Center Sakura Hospital
RECRUITING
Fuji-shi
Niigata Cancer Center Hospital
RECRUITING
Niigata
Japanese Red Cross Osaka Hospital
RECRUITING
Osaka
Ukraine
Arensia Kapitanivka - PPDS
RECRUITING
Kapitanivka
Contact Information
Primary
Chief Scientific Operations Officer
clinicaltrials@protaratx.com
16468440337
Time Frame
Start Date:2023-09-15
Estimated Completion Date:2030-08
Participants
Target number of participants:131
Treatments
Experimental: TARA-002
TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain.