Actively Recruiting
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Led by Protara Therapeutics · Updated on 2026-01-27
131
Participants Needed
61
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- 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
You will not qualify if you...
- Penicillin allergy (participants with questionable history will undergo penicillin blood allergy testing)
- Central confirmed variant histology
- Concomitant prostatic or upper tract urothelial involvement
- Nodal and metastatic disease present at any time
- Any history of stage T2 or higher bladder cancer at any time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 61 locations
1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
Actively Recruiting
2
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
East Valley Urology Center of Arizona
Queen Creek, Arizona, United States, 85140
Actively Recruiting
4
Arkansas Urology
Little Rock, Arkansas, United States, 72211
Actively Recruiting
5
Michael Oefelein Clinical Trials
Bakersfield, California, United States, 93301
Actively Recruiting
6
Urology Group of Southern California
Los Angeles, California, United States, 90017
Actively Recruiting
7
University of California Irvine Medical Center
Orange, California, United States, 92697
Actively Recruiting
8
Genesis Research
San Diego, California, United States, 92123
Withdrawn
9
Genesis Research LLC
Torrance, California, United States, 90505
Actively Recruiting
10
Colorado University - Anshutz
Aurora, Colorado, United States, 80045
Actively Recruiting
11
AdventHealth Medical Group Urology of Denver
Denver, Colorado, United States, 80211
Actively Recruiting
12
Advanced Urology
Lakewood, Colorado, United States, 80228
Actively Recruiting
13
Urology Associates of Denver
Lone Tree, Colorado, United States, 80124
Actively Recruiting
14
University of Florida Health Jacksonville
Gainesville, Florida, United States, 32611
Withdrawn
15
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
16
Comprehensive Urologic Care
Lake Barrington, Illinois, United States, 60010
Actively Recruiting
17
Southern Urology
Lafayette, Louisiana, United States, 70508
Actively Recruiting
18
Ochsner Health LSU - Regional Urology
Shreveport, Louisiana, United States, 71105
Withdrawn
19
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
20
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
21
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
22
Specialty Clinic Research of St. Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
23
AccuMed Research Associates
Garden City, New York, United States, 11530
Terminated
24
University of Rochester, Department of Urology
Rochester, New York, United States, 14642
Actively Recruiting
25
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
26
University of Toledo
Toledo, Ohio, United States, 43606
Withdrawn
27
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
28
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
29
Conrad Person Clinic
Memphis, Tennessee, United States, 38128
Actively Recruiting
30
Urology Associates PC
Nashville, Tennessee, United States, 37209
Actively Recruiting
31
Amarillo Urology Research
Amarillo, Texas, United States, 79106
Withdrawn
32
Urology Partners of North Texas
Arlington, Texas, United States, 76017
Actively Recruiting
33
Urology Austin, LLC
Austin, Texas, United States, 78745
Actively Recruiting
34
Houston Metro Urology
Houston, Texas, United States, 77027
Actively Recruiting
35
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
36
Clinical Trial Network
Houston, Texas, United States, 77074
Withdrawn
37
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
38
Virginia Urology
Richmond, Virginia, United States, 23235
Actively Recruiting
39
Centro Argentino de Urologia
CABA, Argentina, C1419
Actively Recruiting
40
Hospital Sirio Libanes
CABA, Argentina, C1419
Actively Recruiting
41
Centro Urologico Profesor Bengio SA
Córdoba, Argentina, X5000KPH
Actively Recruiting
42
CEMAIC
Córdoba, Argentina, X5088
Actively Recruiting
43
Clinica Privada Independencia
Munro, Argentina, 1605
Actively Recruiting
44
Fuji City General Hospital
Nova Lima, Minas Gerais, Brazil, 34006-059
Actively Recruiting
45
Kyushu University Hospital
Nova Lima, Minas Gerais, Brazil, 34006-059
Actively Recruiting
46
Office of Lucas Nougeria MA
Nova Lima, Minas Gerais, Brazil, 34006-059
Actively Recruiting
47
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-070
Actively Recruiting
48
Nucleo de Pesquisa Clinica do Rio Grande so Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
Actively Recruiting
49
Centro de Urologia Avancada
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
Actively Recruiting
50
Komaki City Hospital
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
Actively Recruiting
51
Hospital de Clinicas da UNICAMP
Campinas, São Paulo, Brazil, 13083-970
Actively Recruiting
52
Instituto Dor de Pesquisa e Ensino
Jardim Paulista, São Paulo, Brazil, 01401-002
Actively Recruiting
53
Faculdade de Medicina ABC-CEPHO
Santo André, São Paulo, Brazil, 09060-650
Actively Recruiting
54
Exdeo Clinical Research Inc
Abbotsford British Columbia, British Columbia, Canada, V2T 1X8
Actively Recruiting
55
Jonathan Giddes Medicine Professional Corporation
Brampton, Ontario, Canada, L6T 4S5
Withdrawn
56
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Withdrawn
57
UHN Princess Margaret Cancer Centre Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
58
Niigata Cancer Center Hospital
Niigata, Niigata, Japan, 961-8566
Actively Recruiting
59
Japanese Red Cross Osaka Hospital
Osaka, Osaka, Japan, 543-855
Actively Recruiting
60
Tokyo University Medical Center Sakura Hospital
Fuji-shi, Shizuoka, Japan, 417-8567
Actively Recruiting
61
Arensia Kapitanivka - PPDS
Kapitanivka, Ukraine, 08111
Actively Recruiting
Research Team
C
Chief Scientific Operations Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here