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

A Phase 1b/2, Dose Expansion, 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

INTRODUCTION

  • Org Study ID: TARA-002-101-Ph1b/2
  • Secondary ID: N/A
  • NCT ID: NCT05951179
  • Sponsor: Protara Therapeutics

BRIEF SUMMARY

TARA-002-101-Ph1b/2 is an open-label Phase 1b/2 dose expansion study to investigate the safety and anti-tumor activity of intravesical treatment of high-grade CIS NMIBC (± Ta/T1) with intravesical instillation of TARA-002 in adults 18 years of age or older.

The Phase 1b/2 study (TARA-002-101-Ph1b/2) will be initiated after the RP2D has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).

This Phase 1b/2 (TARA-002-101-Ph1b/2) dose expansion 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 unable to obtain intravesical BCG, or
* Participants with CIS (± Ta/T1) who have not received intravesical BCG for 24 months prior to CIS diagnosis

Cohort B:

* Participants with CIS (± Ta/T1) who are BCG unresponsive after 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
    PHASE1, PHASE2
  • 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 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

- * Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease

- * Subjects who are unable to obtain intravesical BCG, have not received intravesical BCG for 24 months prior to CIS diagnosis, or have persistent or recurrent CIS (± Ta/T1) within 12 months of completion of adequate BCG
Exclusion Criteria:
* Penicillin allergy (subjects 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 subject'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: AccuMed Research Associates
Garden City, New York 11530
United States 		Status: Recruiting Contact: Contact
Use Central Contact
Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States 		Status: Recruiting Contact: Contact
Use Central Contact
Facility: Urology Associates PC
Nashville, Tennessee 37209
United States 		Status: Recruiting Contact: Contact
Use Central Contact
Facility: Virginia Urology
Richmond, Virginia 23235
United States 		Status: Recruiting Contact: Contact
Use Central Contact

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