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Study on the Safety and Effectiveness of Alpha1H for Adults with Non-Muscle Invasive Bladder Cancer Awaiting Tumor Removal Surgery

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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 non-muscle invasive bladder cancer, a type of bladder cancer that has not spread into the muscle layer of the bladder. The study will evaluate a treatment called Alpha1H, which is a solution used for instillation directly into the bladder. The purpose of the study is to assess the safety and effectiveness of Alpha1H in patients who are waiting for surgery to remove their bladder tumor.

Participants in the study will receive either the Alpha1H treatment or a placebo. The treatment involves placing the solution into the bladder through a process called intravesical instillation, which means the solution is delivered directly into the bladder. The study will monitor how the treatment affects the cancer, including any changes in the size and shape of the tumor, and whether it causes cancer cells to shed into the urine. The study will also look at how the treatment affects the body overall, including any side effects that may occur.

The trial will include various assessments to understand the impact of Alpha1H on the cancer and the body. These assessments will involve examining the tumor tissue and urine samples to see how the treatment works at a cellular level. The study aims to provide valuable information about the potential benefits and safety of using Alpha1H for treating non-muscle invasive bladder cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study involves adult patients with non-muscle invasive bladder cancer who are awaiting surgery to remove the tumor.
Participants must provide signed and dated informed consent to join the study.
Eligibility includes being 18 years or older, having a negative pregnancy test for women of childbearing potential, and using appropriate contraception methods during the study.
Step 2
Treatment administration
The study drug, Alpha1H, is administered through a process called intravesical instillation, which involves delivering the solution directly into the bladder.
Participants will receive either the Alpha1H solution or a placebo solution.
The treatment aims to evaluate the safety and effectiveness of Alpha1H in reducing tumor size and changing its shape.
Step 3
Monitoring and evaluation
Throughout the trial, adverse events will be monitored, including any local or systemic reactions to the treatment.
Vital signs, ECG, and laboratory parameters will be assessed to ensure safety.
The response of the tumor to Alpha1H will be evaluated using imaging techniques during cystoscopy, and the resected tumor will be analyzed through histopathology.
Step 4
Urine analysis
Urine samples will be collected to measure cell shedding, which serves as a biomarker for tumor response.
Changes in protein markers and apoptotic changes in shed cells will be analyzed before and after the Alpha1H instillation.
Step 5
Tissue analysis
Biopsies will be taken to assess tissue changes using histopathology and immunohistochemistry.
The uptake of Alpha1H by tumor tissue will be quantified and compared to healthy tissue.
Gene expression analysis will be conducted to study changes in cancer-associated pathways.
Step 6
Completion of the study
The study is expected to conclude by November 30, 2026.
Participants will be monitored for 30 days after the last treatment to collect data on any adverse events.

Who can join the trial?

7 criteria

Must have signed and dated an informed consent form, which means you agree to participate in the study after understanding what it involves.
Must have a type of bladder cancer called non-muscle invasive papillary bladder cancer (NMIBC), which is a cancer that has not spread into the muscle layer of the bladder. This should be confirmed by a procedure called cystoscopy, where a doctor looks inside the bladder with a special camera.
Must be on the waiting list for a surgery called transurethral resection of the bladder (TURB), which is a procedure to remove bladder tumors.
Both men and women can participate, but you must be 18 years or older.
If you are a woman who can have children, you must have a negative pregnancy test before joining the study.
If you are a woman who can have children, you must use appropriate methods of birth control during the study.
You must be able to hold the contents of your bladder for at least one hour.

Who cannot join the trial?

4 criteria

Patients who have a different type of bladder cancer that is not classified as non-muscle invasive bladder cancer. This type of cancer is limited to the inner layers of the bladder and has not spread to the muscle layer.
Patients who have already undergone the planned transurethral surgery. This is a procedure where a doctor removes bladder tumors using a tool inserted through the urethra.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Fakultni nemocnice Motol a Homolka
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Prague, Czechia

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Investigated drugs

Alpha1H is a medication being studied for its potential to treat 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 safety and effectiveness in reducing or eliminating cancer cells in patients who are awaiting surgery.

Alpha1H

What is already known about the treatment

Alpha1H – Alpha1H is administered through intravesical instillation, meaning it is directly introduced into the bladder. It is currently being studied in clinical trials, specifically a Phase I/II study, to assess its safety and effectiveness in treating non-muscle invasive bladder cancer in patients awaiting transurethral surgery. The main therapeutic indication for Alpha1H is to target bladder cancer cells, potentially reducing tumor size or preventing progression. At the molecular level, Alpha1H is believed to work by inducing cancer cell death and disrupting tumor growth pathways. It is classified pharmacologically as an investigational agent, as it is still under evaluation in clinical research.

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. It often presents with symptoms such as blood in the urine, frequent urination, or pain during urination. The disease is typically detected through imaging tests or cystoscopy, where a camera is used to view the inside of the bladder. Over time, if not managed, the cancer can progress to invade deeper layers of the bladder wall. The progression of the disease is monitored through regular follow-ups and imaging to assess any changes in the tumor's size or characteristics.