Recruiting

Study of EG-70 for Patients with Non-Muscle Invasive Bladder Cancer Unresponsive to BCG or High-Risk Patients New to BCG or with Incomplete BCG Treatment

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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 Non-Muscle Invasive Bladder Cancer (NMIBC). The study is investigating a new treatment called EG-70, which is a solution for infusion. EG-70 contains a special type of DNA that helps the body produce a protein called Interleukin 12, which can boost the immune system to fight cancer cells. The trial is specifically for patients whose cancer has not responded to a common treatment called BCG or who have not completed BCG treatment.

The purpose of the study is to evaluate how effective and safe EG-70 is when given directly into the bladder. The study will observe patients over a period of time to see if the cancer responds to the treatment. Patients will receive the treatment through a process called intravesical administration, which means the medication is delivered directly into the bladder. The study will monitor the patients' response to the treatment at different intervals, such as 12, 24, 36, and 48 weeks, to see if there is a complete response, meaning no signs of cancer are found.

Throughout the study, the safety of EG-70 will be closely monitored by checking for any side effects. The trial will also look at how the treatment affects the patients' quality of life and other health markers. The study aims to provide valuable information on whether EG-70 can be a beneficial treatment option for patients with NMIBC who have limited options due to their cancer not responding to or completing BCG treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The study begins with an initial assessment to confirm eligibility. This includes a review of medical history and current health status.
Tests may include blood tests, urine tests, and imaging to ensure the patient meets the study criteria.
Step 2
Treatment administration
The treatment involves the administration of EG-70, a solution for infusion, directly into the bladder. This is known as intravesical administration.
The frequency and duration of the treatment will be determined by the study protocol and the patient's response to the treatment.
Step 3
Monitoring and follow-up
Regular monitoring will occur throughout the study to assess the patient's response to the treatment and to identify any side effects.
This includes cystoscopic examinations, urine cytology, and biopsies at specified intervals to evaluate the presence of cancer cells.
Step 4
Evaluation of response
The primary goal is to achieve a complete response, meaning no detectable cancer, at 48 weeks.
Secondary evaluations will occur at 12, 24, 36, and 96 weeks to assess the duration of response and progression-free survival.
Step 5
End of study
The study is expected to conclude by September 2028, with final assessments and data collection to evaluate the overall effectiveness and safety of the treatment.

Who can join the trial?

20 criteria

Patients with **Non-muscle invasive bladder cancer (NMIBC)**, which means the cancer is in the bladder but hasn't spread to the muscle layer.
Patients with **BCG-unresponsive NMIBC** who have cancer cells in the bladder lining, with or without small tumors, and are not able or choose not to have their bladder removed. They must have had persistent disease within 12 months or a recurrence within 6 months after completing a specific BCG treatment.
Patients with NMIBC who have current cancer cells in the bladder lining, with or without small tumors, and are not able or choose not to have their bladder removed. They must have had incomplete BCG treatment or no BCG treatment due to unavailability but have had at least one dose of chemotherapy directly into the bladder after a procedure to remove bladder tumors.
Patients who have been treated with a **checkpoint inhibitor** (a type of drug that helps the immune system fight cancer) can join the study 30 days after treatment in Phase 1 or 3 months after treatment in Phase 2.
Must be male or a non-pregnant, non-breastfeeding female, aged 18 years or older.
Women who can have children must have a negative pregnancy test before starting the study.
Women who can have children must agree to use highly effective birth control methods during the study and for 3 months after the study ends (6 months in France). Men must use a condom during the study and for 3 months after the last dose.
In Phase 2, for patients with T1 lesions, a biopsy must include the muscle layer of the bladder.
Must have a **Performance Status** of 0, 1, or 2 according to the Eastern Cooperative Oncology Group, which is a way to measure how well a patient can perform daily activities.
Must have certain blood test results within normal limits, including:
- **Absolute neutrophil count** (a type of white blood cell) greater than 1,500 per mm³.
- **Hemoglobin** (a protein in red blood cells) greater than 9.0 g/dL.
- **Platelet count** (cells that help with blood clotting) greater than 100,000 per mm³.
- Must have certain liver function test results within normal limits, including:
  - **Total bilirubin** (a substance made by the liver) less than or equal to 1.5 times the upper limit of normal.
  - **Aspartate aminotransferase** and **alanine aminotransferase** (enzymes that indicate liver health) less than or equal to 2.5 times the upper limit of normal.
  - **Alkaline phosphatase** (an enzyme related to the liver and bones) less than or equal to 2.5 times the upper limit of normal.
  - Must have adequate kidney function with a **creatinine clearance** (a measure of kidney function) greater than 30 mL/min.
  - Must have certain blood clotting test results within normal limits, including **prothrombin time** and **partial thromboplastin time** less than or equal to 1.25 times the upper limit of normal, or within the therapeutic range if on blood-thinning medication.
  - Must have satisfactory bladder function and be able to hold the study drug in the bladder for at least 60 minutes.
  - The patient or their legally authorized representative must be willing and able to follow all study requirements.
  - The patient or their legally authorized representative must be willing and able to give informed consent and any necessary permissions required by local law to participate in the study.

Who cannot join the trial?

4 criteria

Patients who have a type of bladder cancer called Non-muscle invasive bladder cancer (NMIBC) that does not respond to a treatment called BCG (Bacillus Calmette-Guérin).
Patients with high-risk NMIBC who have not received BCG treatment before or have not completed the BCG treatment.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Responsive
Azienda Ospedaliero-Universitaria Sant Andre
Rome, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

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Investigated drugs

EG-70 is a medication being studied for its effectiveness in treating bladder cancer. It is administered directly into the bladder through a process called intravesical instillation. This study is focused on patients who have a type of bladder cancer that does not respond to a common treatment known as BCG, as well as patients who have not received enough BCG treatment or have never had it. The goal is to see if EG-70 can help reduce or eliminate the cancer and to ensure it is safe for patients to use.

Lauromacrogol 400

What is already known about the treatment

EG-70 – This medication is administered directly into the bladder through a process known as intravesical instillation. It is currently being studied in clinical trials for its effectiveness and safety in treating non-muscle invasive bladder cancer (NMIBC), particularly in patients who do not respond to BCG therapy or have not completed BCG treatment. EG-70 works by stimulating the immune system to target and destroy cancer cells in the bladder. It is classified as an immunotherapy agent, aiming to enhance the body's natural defenses against cancer.

Investigated diseases

Non-muscle invasive bladder cancer (NMIBC) – This type of bladder cancer is characterized by cancerous cells that are confined to the inner layers of the bladder wall and have not spread into the muscle layer. It often presents with symptoms such as blood in the urine, frequent urination, or pain during urination. NMIBC is typically detected through urine tests and cystoscopy, where a camera is used to look inside the bladder. The progression of NMIBC can vary, with some cases remaining stable while others may recur or progress to a more invasive form. Regular monitoring is essential to manage the disease effectively.