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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

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

Must not have

Bladder cancer stage CIS with concomitant T1

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 43

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

Exclusion Criteria

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

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My bladder cancer is at an early stage but has grown into the bladder wall.

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

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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 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

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

Primary study objectives

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

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