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

A Phase 1a/b Dose Finding, Open-label Study to Evaluate Safety and Toxicity of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

INTRODUCTION

  • Org Study ID: TARA-002-101(Phase 1b)
  • Secondary ID: N/A
  • NCT ID: NCT05085990
  • Sponsor: Protara Therapeutics

BRIEF SUMMARY

This study is open-label dose expansion study to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who have received at least one dose of intravesical BCG or adults who have received at least one dose of intravesical chemotherapy.

After completion of the dose escalation phase (Phase 1a) and after the RP2D has been established, the dose expansion phase (Phase 1b) will start enrollment of subjects with CIS NMIBC with active disease to further evaluate the safety and preliminary efficacy of TARA-002, at the established RP2D. CIS NMIBC with active disease is defined as disease present at the last cystoscopic evaluation prior to signing the ICF. Subjects enrolled in the dose expansion phase will not include subjects previously enrolled and treated in the dose escalation phase.

All subjects will receive 6 weeks of treatment at the established RP2D.

  • Overall Status
    Recruiting
  • Start Date
    May 8, 2023
  • Phase
    Phase 1
  • 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

- * Subjects with a histologically confirmed, high-grade Ta or CIS (including CIS with concomitant Ta) urothelial cell carcinoma of the bladder according to central review

- * Subjects who are treatment naïve, unable to obtain intravesical BCG for the treatment of NMIBC, have received at least one dose of intravesical BCG, or at least one dose of intravesical chemotherapy
Exclusion Criteria:
* Penicillin allergy (subjects with a questionable history of allergy to penicillin or no history of penicillin use will undergo penicillin allergy testing prior to inclusion in the study)

- * 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 involvement or metastatic disease that existed at any time (past or present disease)

- * Bladder cancer stage ≥ T1 within the last 36 months according to central histology review

- * Bladder cancer stage CIS with concomitant T1
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: USC Norris Cancer Center
Los Angeles, California 90089
United States 		Status: Recruiting Contact: Contact
Use Central Contact
Facility: Mayo Clinic
Jacksonville, Florida 32224
United States 		Status: Recruiting Contact: Contact
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Facility: Tulane Medical Center (TMC) - Clinic/Outpatient Facility
New Orleans, Louisiana 70112
United States 		Status: Recruiting Contact: Contact
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Facility: Mayo Clinic
Rochester, Minnesota 55905
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: UT Health San Antonio
San Antonio, Texas 78229
United States 		Status: Recruiting Contact: Contact
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