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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 1a)
  • Secondary ID: N/A
  • NTC ID: NCT05085977
  • Sponsor: Protara Therapeutics

BRIEF SUMMARY

This study is an open-label dose escalation study (Phase 1a) to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS) 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. Dosing will start in subjects with HGTa or CIS NMIBC to include a minimum of 1 dosing cohort and a maximum of 3 total dosing cohorts. All subjects will receive 6 weeks of treatment at a fixed volume with varying doses levels.

  • Overall Status
    Not yet recruiting
  • Start Date
    November 2021
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Phase 1a, Dose Escalation Phase: Incidence of DLT AEs in subjects with HGTa or CIS NMIBC

Primary Outcome 1 - Timeframe: Day 1 to Day 43

Primary Outcome 2 - Measure: Phase 1a, Dose Escalation Phase: MTD and RP2D of TARA-002 in subjects with HGTa or CIS NMIBC

Primary Outcome 2 - Timeframe: Day 1 to Day 43

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 urothelial cell carcinoma of the bladder according to American Joint Committee on Cancer staging and 2016 WHO/ISUP grading classification.

- Subjects who are 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 sensitivity testing prior to inclusion in the study)

- Predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components

- Prostatic involvement, upper tract urothelial carcinoma, nodal involvement, or metastatic disease

- Bladder cancer stage ≥ T1 according to American Joint Committee on Cancer staging criteria

- 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