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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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Hospital Universitario 12 De Octubre Madrid Spain
Fundacio Puigvert Barcelona Spain
Hxdsokid Uhpgzayvvfcrw Rgotyken Dh Mpvocl Malaga Spain
Haojvadn Uxfexmbinvjyg Mnqmifs Dg Vegihmaizc Santander Spain
Syozxhbe Cumksn Dd Nshzfxvbus Doz Ctlub Dexajb Bucharest Romania

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Romania Romania
Not yet recruiting
01.11.2023
Spain Spain
Not yet recruiting
01.11.2023

Trial locations

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.

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 ID:
2023-505062-28-00
Protocol code:
TARA-002-101-Ph1b/2
Trial Phase:
Human Pharmacology (Phase I) – Other

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