Brigham Research Institute (BRI) - Brigham and Women's Hospital

Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

Purpose

TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF). Participants will be enrolled into one of 2 cohorts: Cohort A: - Participants with CIS (± Ta/T1) who are BCG naive, or - Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: - Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)

Condition

Non-muscle Invasive Bladder Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Male or female participants 18 years of age or older at the time of signing informed consent - Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry - Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease - Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (Cohort B).

Exclusion Criteria

Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory - 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 and metastatic disease are excluded if they existed at any time (whether present or in the past) - Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history For more information on eligibility criteria, please contact the Sponsor

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive 6 weekly instillations of TARA-002 at the established RP2D (First Treatment Period). Participants who are eligible for reinduction after the First Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part of the Second Treatment Period. Participants confirmed to have a complete response after the First Treatment Period will receive 3 additional weekly doses of TARA-002 instillation as maintenance during the Second Treatment Period. All eligible participants will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment Period (maintenance) at Months 6, 9, 12, 15, and 18. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 21 until Month 60.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental 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.	Biological: TARA-002 All participants will receive 6 weekly instillations of TARA-002 at the established RP2D (First Treatment Period). Participants who are eligible for reinduction after the First Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part of the Second Treatment Period. Participants confirmed to have a complete response after the First Treatment Period will receive 3 additional weekly doses of TARA-002 instillation as maintenance during the Second Treatment Period. All eligible participants will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment Period (maintenance) at Months 6, 9, 12, 15, and 18. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 21 until Month 60.

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115

Contact:
Use Central Contact

More Details

Status: Recruiting
Sponsor: Protara Therapeutics

Study Contact

Chief Scientific Operations Officer
16468440337
clinicaltrials@protaratx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.