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

Phase 1

Completed

Brief Summary: This study is open-label dose expansion study 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.

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.

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 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

Penicillin allergy (subjects with a questionable history of allergy to penicillin or no history of penicillin use will undergo penicillin 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 1b, Dose Expansion Phase: Incidence of AEs in subjects with CIS NMIBC with active disease	Day 1 to Day 78	AE = adverse event

Secondary Outcome Measures

Name	Time	Method

Locations (9): Chesapeake Urology Research Associates
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Baltimore, Maryland, United States
Urology Associates PC
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Nashville, Tennessee, United States
Carolina Urologic Research Center
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Myrtle Beach, South Carolina, United States
Tulane Medical Center (TMC) - Clinic/Outpatient Facility
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New Orleans, Louisiana, United States
Mayo Clinic
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Rochester, Minnesota, United States
USC Norris Cancer Center
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Los Angeles, California, United States
Premier Medical Group of the Hudson Valley
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Poughkeepsie, New York, United States
UT Health San Antonio
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San Antonio, Texas, United States
University of Rochester, Department of Urology
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Rochester, New York, United States