TARA-002 for Bladder Cancer

(ADVANCED-1 Trial)

Recruiting at 13 trial locations

Overseen By Chief Scientific Operations Officer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Protara Therapeutics

Disqualifiers: Penicillin allergy, Adenocarcinoma, Metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

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.

Research Team

Chief Scientific Operations Officer

Principal Investigator

Protara Therapeutics

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

Subjects who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry

I have bladder cancer and have either not started treatment, can't get BCG therapy, or have already received at least one dose of BCG or chemotherapy.

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

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.

You have a possible allergy to penicillin, or you have never used penicillin before and need to have a blood test to check for an allergy before joining the study.

Treatment Details

Interventions

• TARA-002

Trial Overview 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.

Participant Groups

Group I: TARA-002 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Protara Therapeutics

Lead Sponsor

Trials

5

Recruited

270+