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

Phase 1

Active, not recruiting

Brief 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), and all subjects will receive 6 weeks of treatment at a fixed volume with varying dose levels.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
TARA-002	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.

Primary Outcome Measures

Name	Time	Method
Phase 1a, Dose Escalation Phase: MTD and RP2D of TARA-002 in subjects with HGTa or CIS NMIBC	Day 1 to Day 43	MTD = maximum tolerated dose; RP2D = recommended Phase 2 dose
Phase 1a, Dose Escalation Phase: Incidence of DLT AEs in subjects with HGTa or CIS NMIBC	Day 1 to Day 43	DLT = dose limiting toxicities; HGTa = high grade Ta; CIS = carcinoma in situ, includes CIS with concomitant Ta

Secondary Outcome Measures

Name	Time	Method

Locations (13): New Jersey Urology
🇺🇸
Mount Laurel, New Jersey, United States
Carolina Urologic Research Center
🇺🇸
Myrtle Beach, South Carolina, United States
PMSI Republican Clinical Hospital "T. Mosneaga," ARENSIA Exploratory Medicine Phase I Unit
🇲🇩
Chisinau, Moldova, Republic of
Spitalul Clinic de Nefrologie Carol Davila
🇷🇴
Bucharest, Romania
Arensia Kapitanivka
🇺🇦
Kapitanivka, Ukraine
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Urology Associates PC
🇺🇸
Nashville, Tennessee, United States
USC Norris Cancer Center
🇺🇸
Los Angeles, California, United States
Chesapeake Urology Research Associates
🇺🇸
Baltimore, Maryland, 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
UT Health San Antonio
🇺🇸
San Antonio, Texas, United States
Tulane Medical Center
🇺🇸
New Orleans, Louisiana, United States