Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1a)
NCT ID: NCT05085977
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2022-03-10
2024-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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TARA-002
TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin.
TARA-002
Phase 1a, Dose Escalation: First, up to 3 dose levels of TARA-002 (10 KE → 20 KE → 40 KE) will be tested sequentially with 6 weekly intravesical doses starting with the lowest dose using a 3+3 design in a dose escalation manner until the RP2D has been established. If the MTD is not reached, additional cohorts of dose levels higher than 40 KE may be explored.
Interventions
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TARA-002
Phase 1a, Dose Escalation: First, up to 3 dose levels of TARA-002 (10 KE → 20 KE → 40 KE) will be tested sequentially with 6 weekly intravesical doses starting with the lowest dose using a 3+3 design in a dose escalation manner until the RP2D has been established. If the MTD is not reached, additional cohorts of dose levels higher than 40 KE may be explored.
Eligibility Criteria
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Inclusion Criteria
* Subjects who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
* Subjects with a histologically confirmed, high-grade Ta or CIS (including CIS with concomitant Ta) urothelial cell carcinoma of the bladder on central review
* Subjects who are treatment naïve, are unable to obtain intravesical BCG for the treatment of NMIBC, have received at least one dose of intravesical BCG, or at least one dose of intravesical chemotherapy
Exclusion Criteria
* Predominant (defined as \> 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review
* Concomitant prostatic or upper tract urothelial involvement, per Investigator's assessment
* Nodal involvement or metastatic disease that existed at any time (past or present disease)
* Bladder cancer stage ≥ T1 within the last 36 months according to central histology review
* Bladder cancer stage CIS with concomitant T1
For more information on eligibility criteria, please contact the sponsor.
18 Years
ALL
No
Sponsors
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Protara Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Scientific Operations Officer
Role: STUDY_DIRECTOR
Protara Therapeutics
Locations
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USC Norris Cancer Center
Los Angeles, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
New Jersey Urology
Mount Laurel, New Jersey, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
University of Rochester, Department of Urology
Rochester, New York, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates PC
Nashville, Tennessee, United States
UT Health San Antonio
San Antonio, Texas, United States
PMSI Republican Clinical Hospital "T. Mosneaga," ARENSIA Exploratory Medicine Phase I Unit
Chisinau, , Moldova
Spitalul Clinic de Nefrologie Carol Davila
Bucharest, , Romania
Arensia Kapitanivka
Kapitanivka, , Ukraine
Countries
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Other Identifiers
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TARA-002-101 (Phase 1a)
Identifier Type: -
Identifier Source: org_study_id
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