TARA-002 for Bladder Cancer

(ADVANCED-1 Trial)

No longer recruiting at 14 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

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called TARA-002 for individuals with high-grade bladder cancer that hasn't spread beyond the bladder lining. The goal is to determine the safety of TARA-002 and identify the right dose for patients. It targets those who have either tried bladder cancer treatments like BCG (a type of bladder cancer therapy) or chemotherapy, or who can't access BCG treatment. Individuals diagnosed with high-grade Ta or CIS bladder cancer might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

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.

Is there any evidence suggesting that TARA-002 is likely to be safe for humans?

Research has shown that TARA-002 is generally well-tolerated by patients. In earlier studies, patients responded well to the treatment and experienced few serious side effects. For example, one study found that 72% of patients had a complete response after six months, meaning their cancer improved significantly or disappeared. Importantly, these studies did not raise major safety concerns about the treatment. This suggests TARA-002 is safe for humans, although this trial aims to learn more about its safety and the optimal dose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for bladder cancer, which often include surgery, chemotherapy, or immunotherapy, TARA-002 is unique because it uses a biological approach. This treatment contains cells from Streptococcus pyogenes, a type of bacteria, which are treated with benzylpenicillin. Researchers are excited about TARA-002 because it might stimulate the immune system to attack cancer cells more effectively. This novel approach could offer a new option for patients who may not respond well to traditional therapies.

What evidence suggests that TARA-002 might be an effective treatment for bladder cancer?

Studies have shown that TARA-002 offers promising results for treating high-grade non-muscle invasive bladder cancer (NMIBC). In earlier trials, TARA-002 enabled all patients to achieve a complete response at some point, with 67% maintaining a positive response after 12 months, even if they did not respond to Bacillus Calmette-Guérin (BCG) treatment. Additionally, 72% of patients achieved a complete response after six months, regardless of prior BCG treatment. These findings suggest that TARA-002 could be a strong option for those unable to use or who have not responded well to BCG. ^{2 3 4 5 6}

Who Is on the Research Team?

Chief Scientific Operations Officer

Principal Investigator

Protara Therapeutics

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravesical instillation of TARA-002 for 6 weeks to evaluate safety and toxicity

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ir.protaratx.com ir.protaratx.com/news-releases/news-release-details/protara-therapeutics-announces-positive-interim-results

Press Release TARA-002 demonstrates 100% complete response rate at any time and 67% 12-month landmark complete response rate in BCG-Unresponsive patients

2. ir.protaratx.com ir.protaratx.com/news-releases/news-release-details/protara-announces-positive-results-ongoing-phase-2-advanced-2

Protara Announces Positive Results from the Ongoing ... TARA-002 demonstrates 72% six-month landmark complete response rate and 70% complete response rate at any time across BCG exposures; 100% six-month landmark ...

3. auajournals.org auajournals.org/doi/10.1097/01.JU.0001109740.05294.af.40

IP02-40 PRELIMINARY ANTI-TUMOR ACTIVITY AND ... CONCLUSIONS: Preliminary data from the ADVANCED-2 study suggests that TARA-002 monotherapy is well-tolerated with encouraging anti-tumor ...

4. urotoday.com urotoday.com/conference-highlights/suo-2024/suo-2024-bladder-cancer/156746-suo-2024-advanced-2-phase-2-open-label-study-to-evaluate-safety-and-anti-tumor-activity-of-intravesical-instillation-of-tara-002-in-adults-with-high-grade-non-muscle-invasive-bladder-cancer.html

SUO 2024: ADVANCED-2: Phase 2 Open-Label Study to ... TARA-002 appears to be well-tolerated with encouraging efficacy, showing a 72% high-grade complete response (HG-CR) at 6 months and durability ...

5. urologytimes.com urologytimes.com/view/advanced-2-data-demonstrate-safety-efficacy-of-tara-002-in-nmibc

ADVANCED-2 data demonstrate safety, efficacy of TARA- ... TARA-002 showed a 70% high-grade complete response rate in NMIBC patients, with 72% at six months. The treatment was effective in both BCG- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05951179

NCT05951179 | Safety and Efficacy Study of Intravesical ... 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 ...