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Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer (ADVANCED-2)

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ClinicalTrials.gov Identifier: NCT05951179
Recruitment Status : Recruiting
First Posted : July 18, 2023
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Protara Therapeutics

Study Description
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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)

Condition or disease Intervention/treatment Phase
Non-muscle Invasive Bladder Cancer Biological: TARA-002 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 127 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study to Evaluate Safety and Anti-Tumor Activity, of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer
Actual Study Start Date : September 15, 2023
Estimated Primary Completion Date : May 2030
Estimated Study Completion Date : August 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002 [ Time Frame: Month 3 to Month 60 ]
  2. Cohort A: Incidence of high-grade Complete Response at any time by subgroup (BCG naive and BCG exposed > 24 months) according to central pathology after treatment with TARA-002 [ Time Frame: Month 3 to Month 60 ]

Secondary Outcome Measures :
  1. Cohort A and B: Duration of high-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002 [ Time Frame: Month 3 to Month 60 ]
  2. Cohort A and B: High-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002 [ Time Frame: Month 3 to Month 60 ]
  3. Cohort A and B: Duration of Complete Response (all recurrent bladder cancer, including low grade Ta) after treatment with TARA-002 [ Time Frame: Month 3 to Month 60 ]
  4. Cohort A and B: Complete Response rate (all recurrent bladder cancer, including low grade Ta) at Months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002 [ Time Frame: Month 3 to Month 60 ]
  5. Cohort A and B: Progression free survival after treatment with TARA-002 [ Time Frame: 60 months ]
  6. Cohort A and B: Disease-specific progression free survival after treatment with TARA-002 [ Time Frame: 60 months ]
  7. Cohort A and B: Overall survival after treatment with TARA-002 [ Time Frame: 60 months ]
  8. Cohort A and B: Disease specific survival after treatment with TARA-002 [ Time Frame: 60 months ]
  9. Cohort A and B: Time to cystectomy after treatment with TARA-002 [ Time Frame: 60 months ]
  10. Cohort A and B: Time to recurrence delayed cystectomy after treatment with TARA-002 [ Time Frame: 60 months ]
  11. Cohort A and B: Time to progression after treatment with TARA-002 [ Time Frame: 60 months ]
  12. Cohort A and B: Time to disease worsening after treatment with TARA-002 [ Time Frame: 60 months ]
  13. Cohort A and B: Incidence and severity of AEs, TEAEs, SAEs and TESAEs after treatment with TARA-002 [ Time Frame: Day 1 to Month 60 ]
    AE = adverse event; TEAE = treatment emergent adverse event; SAE = serious adverse event; TESAE = treatment emergent serious adverse event

  14. Cohort A and B: Change from baseline in urine pharmacodynamic biomarker levels (including IL-6, IL-8, IFN-γ, and TNF-α) after treatment with TARA-002 [ Time Frame: Day 1 to Day 72 ]
  15. Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-NMIBC24 [ Time Frame: Day 1 to Month 24 ]
    EORTC = European Organization for Research and Treatment of Cancer; QLQ-NMIBC24 = Questionnaire for Patients with NMIBC

  16. Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-C30 [ Time Frame: Day 1 to Month 24 ]
    EORTC = European Organization for Research and Treatment of Cancer; QLQ-C30 = Questionnaire for Patients with Cancer


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05951179


Contacts
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Contact: Chief Scientific Operations Officer 16468440337 clinicaltrials@protaratx.com

Locations
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United States, California
Urology Group of Southern California Recruiting
Los Angeles, California, United States, 90017
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
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United States, New York
AccuMed Research Associates Recruiting
Garden City, New York, United States, 11530
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University of Rochester, Department of Urology Recruiting
Rochester, New York, United States, 14642
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United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
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United States, Tennessee
Urology Associates PC Recruiting
Nashville, Tennessee, United States, 37209
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United States, Texas
Urology Austin, LLC Recruiting
Austin, Texas, United States, 78745
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Clinical Trial Network Recruiting
Houston, Texas, United States, 77074
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United States, Virginia
Virginia Urology Recruiting
Richmond, Virginia, United States, 23235
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Ukraine
Arensia Kapitanivka - PPDS Recruiting
Kapitanivka, Ukraine, 08111
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Sponsors and Collaborators
Protara Therapeutics
Investigators
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Study Director: Chief Scientific Operations Officer Protara Therapeutics
More Information
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Responsible Party: Protara Therapeutics
ClinicalTrials.gov Identifier: NCT05951179    
Other Study ID Numbers: TARA-002-101-Ph2
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Protara Therapeutics:
Non-muscle invasive bladder Cancer
bladder cancer
high grade Ta
high grade NMIBC
carcinoma in situ
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type