Bladder Cancer Clinical Trial

Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer (Phase 1a)

Summary

This study is an open-label dose escalation study (Phase 1a) to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who have received at least one dose of intravesical BCG or adults who have received at least one dose of intravesical chemotherapy. Dosing will start in subjects with HGTa or CIS (including CIS with concomitant Ta) NMIBC to include a minimum of 1 dosing cohort and a maximum of 3 total dosing cohorts. All subjects will receive 6 weeks of treatment at a fixed volume with varying dose levels.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female subjects 18 years of age or older at the time of signing the informed consent
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:

Penicillin allergy (subjects with a questionable history of allergy to penicillin or no history of penicillin use will undergo penicillin blood allergy testing prior to inclusion in the study)
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.

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT05085977

Recruitment Status:

Recruiting

Sponsor:

Protara Therapeutics

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There are 13 Locations for this study

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USC Norris Cancer Center
Los Angeles California, 90089, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Tulane Medical Center
New Orleans Louisiana, 70112, United States
Chesapeake Urology Research Associates
Baltimore Maryland, 21204, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
New Jersey Urology
Mount Laurel New Jersey, 08054, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie New York, 12603, United States
University of Rochester, Department of Urology
Rochester New York, 14642, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Urology Associates PC
Nashville Tennessee, 37209, United States
UT Health San Antonio
San Antonio Texas, 78229, United States
PMSI Republican Clinical Hospital "T. Mosneaga," ARENSIA Exploratory Medicine Phase I Unit
Chisinau , , Moldova, Republic of More Info
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Spitalul Clinic de Nefrologie Carol Davila
Bucharest , 10731, Romania
Arensia Kapitanivka
Kapitanivka , 08111, Ukraine More Info
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How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT05085977

Recruitment Status:

Recruiting

Sponsor:


Protara Therapeutics

How clear is this clinincal trial information?

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