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

PHASE2RecruitingINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

September 15, 2023

Primary Completion Date

May 31, 2030

Study Completion Date

August 31, 2030

Conditions
Non-muscle Invasive Bladder Cancer
Interventions
BIOLOGICAL

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.

Trial Locations (42)

1605

RECRUITING

Clinica Privada Independencia, Munro

10467

RECRUITING

Montefiore Medical Center, The Bronx

11530

TERMINATED

AccuMed Research Associates, Garden City

14642

RECRUITING

University of Rochester, Department of Urology, Rochester

23235

RECRUITING

Virginia Urology, Richmond

29572

RECRUITING

Carolina Urologic Research Center, Myrtle Beach

32224

RECRUITING

Mayo Clinic, Jacksonville

32611

RECRUITING

University of Florida Health Jacksonville, Gainesville

37209

RECRUITING

Urology Associates PC, Nashville

38128

RECRUITING

Conrad Person Clinic, Memphis

43606

RECRUITING

University of Toledo, Toledo

55905

RECRUITING

Mayo Clinic, Rochester

70508

RECRUITING

Southern Urology, Lafayette

71105

WITHDRAWN

Ochsner Health LSU - Regional Urology, Shreveport

76017

RECRUITING

Urology Partners of North Texas, Arlington

77027

RECRUITING

Houston Metro Urology, Houston

77030

RECRUITING

Houston Methodist Hospital, Houston

77074

WITHDRAWN

Clinical Trial Network, Houston

78229

RECRUITING

UT Health San Antonio, San Antonio

78745

RECRUITING

Urology Austin, LLC, Austin

80045

RECRUITING

Colorado University - Anshutz, Aurora

80124

RECRUITING

Urology Associates of Denver, Lone Tree

80228

RECRUITING

Advanced Urology, Lakewood

85054

RECRUITING

Mayo Clinic, Phoenix

90017

RECRUITING

Urology Group of Southern California, Los Angeles

92123

WITHDRAWN

Genesis Research, San Diego

92697

RECRUITING

University of California Irvine Medical Center, Orange

02115

RECRUITING

Brigham and Women's Hospital, Boston

C1419

RECRUITING

Centro Argentino de Urologia, CABA

RECRUITING

Hospital Sirio Libanes, CABA

X5000KPH

RECRUITING

Centro Urologico Profesor Bengio SA, Córdoba

X5088

RECRUITING

CEMAIC, Córdoba

90035-070

RECRUITING

Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90430-001

RECRUITING

Nucleo de Pesquisa Clinica do Rio Grande so Sul, Porto Alegre

01401-002

RECRUITING

Instituto Dor de Pesquisa e Ensino, Jardim Paulista

09060-650

RECRUITING

Faculdade de Medicina ABC-CEPHO, Santo André

V2T 1X8

RECRUITING

Exdeo Clinical Research Inc, Abbotsford

L6T 4S5

WITHDRAWN

Jonathan Giddes Medicine Professional Corporation, Brampton

M4N 3M5

WITHDRAWN

Sunnybrook Research Institute, Toronto

M5G 1Z5

RECRUITING

UHN Princess Margaret Cancer Centre Princess Margaret Hospital, Toronto

417-8567

RECRUITING

Tokyo University Medical Center Sakura Hospital, Fuji-shi

08111

RECRUITING

Arensia Kapitanivka - PPDS, Kapitanivka

Sponsors
All Listed Sponsors
lead

Protara Therapeutics

INDUSTRY