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 efficacy 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 efficacy 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 (within 3 months) prior to signing the 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 who are BCG unresponsive

Condition

  • Non-muscle Invasive Bladder Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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 CIS (± Ta/T1) who are BCG unresponsive.

Exclusion Criteria

  • Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory - Central confirmed variant histology - 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, 15,18, and 24. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 27 until Month 60.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TARA-002 		TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain.
  • 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

Urology Centers of Alabama
Homewood 4067927, Alabama 4829764 35209
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Mayo Clinic
Phoenix 5308655, Arizona 5551752 85054
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East Valley Urology Center of Arizona
Queen Creek 5310193, Arizona 5551752 85140
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Arkansas Urology
Little Rock 4119403, Arkansas 4099753 72211
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Michael Oefelein Clinical Trials
Bakersfield 5325738, California 5332921 93301
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Urology Group of Southern California
Los Angeles 5368361, California 5332921 90017
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University of California Irvine Medical Center
Orange 5379513, California 5332921 92697
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Genesis Research LLC
Torrance 5403022, California 5332921 90505
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Colorado University - Anshutz
Aurora 5412347, Colorado 5417618 80045
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AdventHealth Medical Group Urology of Denver
Denver 5419384, Colorado 5417618 80211
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Advanced Urology
Lakewood 5427946, Colorado 5417618 80228
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Urology Associates of Denver
Lone Tree 5429208, Colorado 5417618 80124
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Mayo Clinic
Jacksonville 4160021, Florida 4155751 32224
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Southern Urology
Lafayette 4330145, Louisiana 4331987 70508
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Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
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Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
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Washington University
St Louis 4407066, Missouri 4398678 63110
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Specialty Clinic Research of St. Louis
St Louis 4407066, Missouri 4398678 63141
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University of Rochester, Department of Urology
Rochester 5134086, New York 5128638 14642
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Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
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University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15213
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Carolina Urologic Research Center
Myrtle Beach 4588718, South Carolina 4597040 29572
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Conrad Person Clinic
Memphis 4641239, Tennessee 4662168 38128
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Urology Associates PC
Nashville 4644585, Tennessee 4662168 37209
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Urology Partners of North Texas
Arlington 4671240, Texas 4736286 76017
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Urology Austin, LLC
Austin 4671654, Texas 4736286 78745
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Houston Metro Urology
Houston 4699066, Texas 4736286 77027
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Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
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UT Health San Antonio
San Antonio 4726206, Texas 4736286 78229
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Virginia Urology
Richmond 4781708, Virginia 6254928 23235
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More Details

NCT ID
NCT05951179
Status
Recruiting
Sponsor
Protara Therapeutics

Study Contact

Chief Scientific Operations Officer
16468440337
clinicaltrials@protaratx.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center