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Cancer Vaccine

TARA-002 for Bladder Cancer (ADVANCED-1 Trial)

Phase 1

Recruiting

Research Sponsored by Protara Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female subjects 18 years of age or older at the time of signing the informed consent

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 78

Awards & highlights

ADVANCED-1 Trial Summary

This trial studies a new drug to treat bladder cancer after TURBT or biopsy, for those who haven't responded to BCG or chemotherapy. Patients will receive 6 weeks of treatment to test safety & efficacy.

Who is the study for?

Adults over 18 with high-grade non-muscle invasive bladder cancer (NMIBC) who are treatment-naive, can't get BCG therapy, or have had at least one dose of intravesical BCG or chemotherapy. Not for those with penicillin allergy, certain types of bladder cancer like adenocarcinoma or squamous cell carcinoma, prostate/upper tract involvement, nodal/metastatic disease, or stage ≥ T1 bladder cancer in the last 3 years.Check my eligibility

What is being tested?

The trial is testing TARA-002 given directly into the bladder after tumor removal surgery in adults with NMIBC. It's an open-label study to find out how safe it is and what side effects it might cause when used instead of BCG therapy which may not be available.See study design

What are the potential side effects?

Potential side effects include local reactions where TARA-002 is instilled in the bladder such as discomfort or pain. Systemic reactions could occur due to absorption including fever, chills, nausea; specific risks will be clearer once more data from the trial emerges.

ADVANCED-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years or older and can give informed consent.

Select...

My bladder cancer is confirmed to be high-grade and non-invasive.

ADVANCED-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 78

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 78

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 78 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1b, Dose Expansion Phase: Incidence of AEs in subjects with CIS NMIBC with active disease

ADVANCED-1 Trial Design

1Treatment groups

Experimental Treatment

Group I: TARA-002Experimental Treatment1 Intervention

TARA-002 is a lyophilized biological preparation for instillation containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Protara TherapeuticsLead Sponsor

4 Previous Clinical Trials

238 Total Patients Enrolled

Chief Scientific Operations OfficerStudy DirectorProtara Therapeutics

4 Previous Clinical Trials

238 Total Patients Enrolled

Media Library

TARA-002 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05085990 — Phase 1

Bladder Cancer Research Study Groups: TARA-002

Bladder Cancer Clinical Trial 2023: TARA-002 Highlights & Side Effects. Trial Name: NCT05085990 — Phase 1

TARA-002 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05085990 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned TARA-002 for medicinal use?

"As TARA-002 is currently in Phase 1 of clinical trials, meaning there is limited evidence for its safety and efficacy, the risk associated with this medication has been rated as a 1."

Answered by AI

At how many venues is this research initiative being conducted?

"This medical study is currently taking patient enrolment at 9 separate sites. These include Jacksonville, Baltimore and Rochester alongside 6 other cities. To make the experience more convenient for participants, it may be beneficial to select a centre closest to oneself."

Answered by AI

What is the cap on participant numbers for this trial?

"12 candidates that meet the required qualifications are necessary for this research. Individuals can join at locations such as Mayo Clinic in Jacksonville, FL or Chesapeake Urology Research Associates in Baltimore, MD."

Answered by AI

Are there any current opportunities available to participate in this trial?

"Affirmative. On clinicaltrials.gov, it is evident that this medical trial has opened recruitment and is currently in search of 12 volunteers across 9 sites. The study was initially posted on April 24th 2023 with the most recent update being May 11th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

2023. "Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05085990.

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