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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

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 43

Awards & highlights

ADVANCED-1 Trial Summary

This trial is testing a new intravesical treatment for high-grade non-muscle invasive bladder cancer (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy. The trial will test different dose levels to see what is safe and effective. All subjects will receive 6 weeks of treatment.

Who is the study for?

Adults over 18 with high-grade non-muscle invasive bladder cancer who are treatment-naive, can't get BCG therapy, or have had at least one dose of BCG or chemotherapy. Not for those with metastatic disease, penicillin allergy without clearance from an allergy test, recent advanced bladder cancer stages, or certain histological variants.Check my eligibility

What is being tested?

The trial is testing TARA-002's safety and toxicity when given directly into the bladder after tumor removal surgery in patients with a specific type of bladder cancer. It's an early-phase study where participants receive six weeks of treatment at different doses to find out what’s safe.See study design

What are the potential side effects?

Specific side effects aren't listed but may include typical reactions related to intravesical treatments such as discomfort during instillation, urinary symptoms like frequency and urgency, possible allergic reactions especially in those sensitive to penicillin components.

ADVANCED-1 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

ADVANCED-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 43

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 43

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 43 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 1a, Dose Escalation Phase: Incidence of DLT AEs in subjects with HGTa or CIS NMIBC

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

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

232 Total Patients Enrolled

Chief Scientific Operations OfficerStudy DirectorProtara Therapeutics

4 Previous Clinical Trials

232 Total Patients Enrolled

Frequently Asked Questions

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

How many participants have registered for this research endeavor?

"Affirmative. The details available on clinicaltrials.gov demonstrate that this medical research is now recruiting patients and has been since its initial posting on March 10th 2022. This trial requires 18 participants from 8 different sites to be enrolled in it."

Answered by AI

How many health facilities are actively conducting this experiment in Canada?

"Presently, 8 participating sites are recruiting for this clinical trial. These locations span from Rochester to Myrtle Beach and beyond. To minimize travel needs, it is beneficial to choose the site nearest you if participation is desired."

Answered by AI

What potential risks are associated with the administration of TARA-002?

"The safety of TARA-002 was estimated to be a 1, as this is considered an initial Phase I study. This indicates that there are only limited clinical data which supports the drug's efficacy and safety."

Answered by AI

Are there still vacancies in this research initiative?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this study is recruiting individuals, having first been posted on March 10th 2022 and last updated November 28th 2022. Eight different sites are seeking 18 patients in total for the trial."

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 (Phase 1a)

2022. "Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer (Phase 1a)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05085977.

All > Toxicity > Bladder Cancer