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Cancer Vaccine

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

Phase 1

Waitlist Available

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

Must not have

Nodal involvement or metastatic disease that existed at any time (past or present disease)

Bladder cancer stage CIS with concomitant T1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 78

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to lymph nodes or other parts of my body.

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My bladder cancer is at an early stage but invasive.

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My cancer is mostly made up of a specific type of cell.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met