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

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Protara Therapeutics

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is an open-label dose escalation study (Phase 1a) to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who have received at least one dose of intravesical BCG or adults who have received at least one dose of intravesical chemotherapy. Dosing will start in subjects with HGTa or CIS (including CIS with concomitant Ta), and all subjects will receive 6 weeks of treatment at a fixed volume with varying dose levels.

Eligibility Criteria

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.

Inclusion Criteria

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

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

Exclusion Criteria

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

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

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

Treatment Details

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.

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.