Study on the Safety and Effectiveness of TARA-002 for Treating High-Grade Non-Muscle Invasive Bladder Cancer

Sponsor: Protara Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05951179

Provider View

This clinical trial is testing a new treatment called TARA-002 to see if it is safe and effective for adults with high-grade non-muscle invasive bladder cancer (NMIBC). The study involves placing the treatment directly into the bladder to target cancer cells.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment, TARA-002, for adults with high-grade non-muscle invasive bladder cancer (NMIBC). This Phase 2 study builds on previous research to determine the best dose and assess how well the treatment works against cancer. Participants will be divided into two groups based on their previous treatment history with a bladder cancer vaccine called BCG. The study aims to see if TARA-002 can help reduce or eliminate cancer in the bladder.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Must provide written consent to participate after understanding the study details.
  • Must have a confirmed diagnosis of high-grade non-muscle invasive bladder cancer (CIS ± Ta/T1) with active disease.
  • For Cohort A: Participants who have never received BCG treatment or have not had BCG treatment for at least 24 months before their most recent cancer diagnosis.
  • For Cohort B: Participants with persistent or returning cancer that did not respond to BCG treatment within 12 months after completing adequate BCG therapy.

Exclusion Criteria

  • Allergy to penicillin (participants with uncertain penicillin allergy will be tested).
  • Predominantly have other types of bladder cancer like adenocarcinoma or squamous cell carcinoma.
  • Cancer involvement in the prostate or upper urinary tract.
  • Any history of bladder cancer that has spread to lymph nodes or other parts of the body.
  • Any history of bladder cancer that is stage T2 or higher.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.