TARA-002 for Bladder Cancer
(ADVANCED-2 Trial)

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Protara Therapeutics

Disqualifiers: Penicillin allergy, Adenocarcinoma, Metastatic disease, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF). Participants will be enrolled into one of 2 cohorts: Cohort A: * Participants with CIS (± Ta/T1) who are BCG naive, or * Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: * Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Chief Scientific Operations Officer

Principal Investigator

Protara Therapeutics

Eligibility Criteria

Adults over 18 with high-grade non-muscle invasive bladder cancer who can't get BCG therapy or haven't had it in the last 24 months, or those not responding to BCG after adequate treatment. Excluded are those with certain types of bladder cancer, a history of more advanced cancer, penicillin allergy, and nodal/metastatic disease.

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

My bladder cancer is confirmed to be high-grade but not muscle-invasive.

I haven't had BCG therapy for my bladder cancer in the last 24 months, or it didn't work within 12 months after finishing it.

See 1 more

Exclusion Criteria

I have had bladder cancer that was larger than a T2 tumor at some point.

You are allergic to penicillin, or you are not sure if you are allergic to penicillin and need to undergo a blood test for penicillin allergy.

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

See 2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravesical instillation of TARA-002 to assess safety and anti-tumor activity

24 months

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Periodic visits for monitoring adverse events and quality of life

Treatment Details

Interventions

TARA-002 (Cancer Vaccine)

Trial OverviewThe study tests TARA-002's safety and effectiveness against bladder cancer when put directly into the bladder. It's for patients who've either never had BCG therapy or didn't respond well to it. The trial has two groups based on their previous response to BCG.

Participant Groups

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.