Investigating TARA-002 for treating high-grade bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study evaluates the safety and anti-tumor activity of TARA-002, administered through intravesical instillation, in adults with high-grade non-muscle invasive bladder cancer (NMIBC). Participants are divided into two cohorts: one for those who are BCG naive or have not received BCG for at least 24 months, and another for those with persistent or recurrent disease who are BCG unresponsive. The study aims to build on findings from a previous Phase 1a dose-finding study to determine the optimal dose and efficacy of TARA-002.

Why it matters

Who can join: the full rules

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 CIS (± Ta/T1) who are BCG unresponsive.

Exclusion Criteria:

* Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
* Central confirmed variant histology
* 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

Where it's running

• Urology Centers of Alabama
  Homewood, Alabama, United States Recruiting
• Mayo Clinic
  Phoenix, Arizona, United States Recruiting
• East Valley Urology Center of Arizona
  Queen Creek, Arizona, United States Recruiting
• Arkansas Urology
  Little Rock, Arkansas, United States Recruiting
• Michael Oefelein Clinical Trials
  Bakersfield, California, United States Recruiting
• University of California Irvine Medical Center
  Orange, California, United States Recruiting

+28 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Chief Scientific Operations Officer
• Email: clinicaltrials@protaratx.com
• Phone: 16468440337

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

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• Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

  This study tests whether adding docetaxel after gemcitabine is better or worse than adding mitomycin C after gemcitabine for people with BCG-unresponsive high-grade non-muscle-invasive bladder cancer.

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• Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?

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  Recruiting at 4 sites Phase 2 Tianjin Medical University Second Hospital · Tianjin and 3 other locations · NCT07625527

• Comparing CT and MRI with VI-RADS for Bladder Cancer Staging

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• Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer

  This treatment will test cretostimogene plus n‑dodecyl‑β‑D‑maltoside in adults whose high‑grade non‑muscle‑invasive bladder cancer did not respond to BCG (carcinoma in situ with or without Ta/T1 tumors).

  Recruiting at 14 sites Phase 2 Lepu Biopharma Co., Ltd. · Beijing, Beijing Municipality and 13 other locations · NCT07283835

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.