Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1b)
NCT ID: NCT05085990
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
10 participants
INTERVENTIONAL
2023-05-08
2024-09-12
Brief Summary
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After completion of the dose escalation phase (Phase 1a) and after the RP2D has been established, the dose expansion phase (Phase 1b) will start enrollment of subjects with CIS NMIBC with active disease to further evaluate the safety and preliminary efficacy of TARA-002, at the established RP2D. CIS NMIBC with active disease is defined as disease present at the last cystoscopic evaluation prior to signing the ICF. Subjects enrolled in the dose expansion phase will not include subjects previously enrolled and treated in the dose escalation phase.
All subjects will receive 6 weeks of treatment at the established RP2D.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
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 1b, Dose Expansion Phase: All subjects will receive 6 weekly doses of TARA-002 at the recommended Phase 2 dose (R2PD)
Interventions
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TARA-002
Phase 1b, Dose Expansion Phase: All subjects will receive 6 weekly doses of TARA-002 at the recommended Phase 2 dose (R2PD)
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 according to central review
* Subjects who are treatment naïve, 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 (TMC) - Clinic/Outpatient Facility
New Orleans, Louisiana, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, 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
Countries
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Other Identifiers
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TARA-002-101(Phase 1b)
Identifier Type: -
Identifier Source: org_study_id
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