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Brief Title: Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

A Phase 2, Open-Label Study to Evaluate the Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer

INTRODUCTION

  • Org Study ID: TARA-002-101-Ph2
  • Secondary ID: N/A
  • NCT ID: NCT05951179
  • Sponsor: Protara Therapeutics

BRIEF SUMMARY

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)

  • Overall Status
    Recruiting
  • Start Date
    September 15, 2023
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Non-muscle Invasive Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Chief Scientific Operations Officer

Role: Study Director

Affiliation: Protara Therapeutics

Overall Contact

Name: Chief Scientific Operations Officer

Phone: 16468440337

Email: clinicaltrials@protaratx.com

LOCATION

Facility Status Contact
Facility: Urology Group of Southern California
Los Angeles, California 90017
United States 		Status: Recruiting Contact: Contact
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Facility: Brigham and Women's Hospital
Boston, Massachusetts 02115
United States 		Status: Recruiting Contact: Contact
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Facility: AccuMed Research Associates
Garden City, New York 11530
United States 		Status: Recruiting Contact: Contact
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Facility: University of Rochester, Department of Urology
Rochester, New York 14642
United States 		Status: Recruiting Contact: Contact
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Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States 		Status: Recruiting Contact: Contact
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Facility: Urology Associates PC
Nashville, Tennessee 37209
United States 		Status: Recruiting Contact: Contact
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Facility: Urology Austin, LLC
Austin, Texas 78745
United States 		Status: Recruiting Contact: Contact
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Facility: Clinical Trial Network
Houston, Texas 77074
United States 		Status: Recruiting Contact: Contact
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Facility: Virginia Urology
Richmond, Virginia 23235
United States 		Status: Recruiting Contact: Contact
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