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Study on the Safety and Effectiveness of TARA-002 for Adults with High-Grade Non-Muscle Invasive Bladder Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of bladder cancer known as high-grade non-muscle invasive bladder cancer. The treatment being tested is called TARA-002, which is a form of inactivated bacteria known as Streptococcus pyogenes. This treatment is administered directly into the bladder through a process called intravesical instillation, which involves placing the medication directly into the bladder.

The purpose of the study is to evaluate the safety and effectiveness of TARA-002 in treating this type of bladder cancer. Participants in the study will receive the treatment and will be monitored for any changes in their condition. The study will also look at how the treatment affects the cancer and any side effects that may occur. The study is divided into two groups, with each group receiving the treatment and undergoing regular check-ups to assess the treatment's impact on their cancer.

Throughout the study, participants will have regular medical evaluations, including procedures like cystoscopy (a test that allows doctors to look inside the bladder), bladder biopsies (taking a small sample of bladder tissue for testing), and urine tests. These evaluations will help determine how well the treatment is working and ensure the safety of the participants. The study aims to provide valuable information on the potential benefits of TARA-002 for people with high-grade non-muscle invasive bladder cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The study begins with the administration of TARA-002, a medication prepared from a lyophilized powder for injection. This medication is administered directly into the bladder, a method known as intravesical use.

    The purpose of this phase is to evaluate the safety and initial anti-tumor effects of the treatment in patients with high-grade non-muscle invasive bladder cancer.

  2. Step 2

    Treatment administration

    The medication is given in a series of doses. The exact schedule and number of doses will be determined by the study protocol and the patient's specific condition.

    During this period, regular monitoring through cystoscopy, bladder biopsy, and urine tests will be conducted to assess the treatment's effects.

  3. Step 3

    Monitoring and evaluation

    Throughout the study, the patient's response to the treatment will be closely monitored. This includes checking for any side effects and measuring the treatment's impact on the cancer.

    The study aims to observe the incidence of complete response (CR) at various time points and assess the duration of any observed responses.

  4. Step 4

    Follow-up phase

    After completing the treatment phase, patients will continue to be monitored for any long-term effects or recurrence of cancer.

    This phase includes regular follow-up visits to evaluate overall survival, progression-free survival, and any changes in quality of life.

Who can join the trial?

12 criteria

  • Participants must be male or female and at least 18 years old.
  • Participants must voluntarily sign a written consent form after understanding the study details.
  • Participants must have a confirmed diagnosis of high-grade non-muscle invasive bladder cancer with active disease. This means the cancer is present but hasn't spread to the muscle.
  • For Cohort A: Participants must have cancer that cannot be treated with a specific bladder cancer treatment called BCG, or they haven't received BCG for 24 months before their diagnosis.
  • For Cohort B: Participants must have cancer that did not respond to BCG treatment within 12 months after completing the treatment.
  • Participants must not have received any other investigational treatments for bladder cancer at least 6 weeks before signing the consent form.
  • The study doctor must believe that participants can follow the study requirements.
  • Participants must have an ECOG performance status of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities.
  • If male participants are sexually active with female partners, they must use a reliable method of birth control and not donate sperm during the study and for 4 weeks after the last dose of the study drug.
  • If female participants are of childbearing age, they must have a negative pregnancy test and use a reliable method of birth control during the study and for 4 weeks after the last dose of the study drug.
  • Participants must have access to the study drug, TARA-002, as confirmed by their doctor.
  • If participants have not been vaccinated against COVID-19, they must test negative for COVID-19 before starting the study treatment.

Who cannot join the trial?

4 criteria

  • Patients with a type of bladder cancer that is not classified as non-muscle invasive bladder cancer cannot participate. This means the cancer has not spread into the muscle layer of the bladder.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to undergo procedures like cystoscopy (a test that allows the doctor to look inside the bladder), bladder biopsy (taking a small sample of bladder tissue for testing), or urine cytology (examining urine cells under a microscope) cannot participate.
  • Patients who are part of a vulnerable population, which may include groups like children, pregnant women, or others who need special protection, cannot participate.
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Investigated drugs

TARA-002 is a medication being studied for its potential to treat high-grade non-muscle invasive bladder cancer. It is administered directly into the bladder through a process called intravesical instillation. The goal of this treatment is to evaluate its ability to reduce or eliminate bladder tumors. The study involves monitoring the effects of TARA-002 on the bladder using various methods such as cystoscopy, bladder biopsy, and urine tests to determine its effectiveness in combating cancer cells.

What is already known about the treatment

TARA-002 – This medication is administered directly into the bladder through a process called intravesical instillation. It is currently being studied in clinical trials for its potential to treat high-grade non-muscle invasive bladder cancer. The main therapeutic indication is to evaluate its anti-tumor activity in this type of cancer. TARA-002 works by stimulating the immune system to attack cancer cells, although the exact molecular mechanism is still under investigation. It is classified as an immunotherapy agent, aiming to enhance the body's natural defenses against cancer.

Investigated diseases

Non-muscle invasive bladder cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not yet invaded the muscle layer of the bladder wall. It often presents with symptoms such as blood in the urine, frequent urination, or pain during urination. The disease can progress by growing into larger tumors or spreading to other parts of the bladder lining. It is typically classified into different grades based on how abnormal the cancer cells look under a microscope, with high-grade tumors being more aggressive. Monitoring and regular check-ups are crucial to detect any changes in the cancer's behavior.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505062-28-00Protocol codeTARA-002-101-Ph1b/2Estimated enrolment102 patientsSponsorProtara Therapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).