TARA-002 for Bladder Cancer

(ADVANCED-2 Trial)

Recruiting at 53 trial locations

Overseen By Chief Scientific Operations Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Protara Therapeutics

Disqualifiers: Penicillin allergy, Adenocarcinoma, Metastatic disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

131 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TARA-002 for individuals with high-grade CIS NMIBC, a type of bladder cancer. The goal is to assess the safety and effectiveness of TARA-002 in fighting tumors when introduced directly into the bladder. Participants will be divided into two groups: those who have never received the common bladder treatment BCG, or haven't received it for at least two years, and those whose cancer did not respond to BCG within a year. Suitable candidates have active non-muscle invasive bladder cancer and a history of poor response to other treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

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.

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

Previous studies have shown that TARA-002 is well tolerated by patients. For instance, research found that TARA-002 was generally safe, with most patients not experiencing severe side effects. Another study reported a high success rate in treating bladder cancer, with 72% of patients showing a complete response at six months. This suggests that TARA-002 is effective and does not cause major issues for most people. While no treatment is without risks, the data so far appears promising in terms of safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bladder cancer?

Most treatments for bladder cancer, like chemotherapy and immunotherapy, work by attacking cancer cells or boosting the immune system to fight cancer. TARA-002 is unique because it uses a lyophilized biological preparation derived from Streptococcus pyogenes cells. Researchers are excited about TARA-002 because it offers a new mechanism of action by potentially stimulating the immune system differently and may provide an alternative for patients who do not respond well to traditional therapies. This innovative approach could lead to more effective treatments with potentially fewer side effects.

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

Research has shown that TARA-002, the investigational treatment in this trial, offers promising results for treating non-muscle invasive bladder cancer (NMIBC). In earlier studies, 70% of patients experienced a complete response, meaning their cancer disappeared. After six months, 72% of these patients still showed no signs of cancer. The treatment works well for patients from various backgrounds, including those who have previously received BCG, a common bladder cancer treatment. Overall, TARA-002 appears to be a well-tolerated and effective option for this type of bladder cancer. ^{1 3 5 6 7}

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 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.

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.

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 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

What Are the Treatments Tested in This Trial?

Interventions

• TARA-002

Trial Overview

The 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.

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.

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-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 ...

2.

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- ...

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05951179

NCT05951179 | Safety and Efficacy Study of Intravesical ...

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 ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1078143924009025

119 advanced-2: phase 2 open-label study to evaluate ...

Preliminary data from the ADVANCED-2 study suggests that TARA-002 appears to be well tolerated, thus demonstrating a favorable tolerability profile for the ...

7.

ir.protaratx.com

ir.protaratx.com/static-files/9c059f45-c37e-40be-9c1f-7c85f2f7c98f

Phase 2 Open-label Study to Evaluate Safety and ...

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