Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Randomized Placebo controlled Phase I/II Study Evaluating the Safety and Efficacy of Alpha1H in adult patients with non-muscle invasive bladder cancer awaiting transurethral surgery

This research trial is for adults with non-muscle invasive bladder cancer and are waiting for surgery. The study is testing a new treatment called Alpha1H to see if it's safe and effective. Participants will either receive Alpha1H or a placebo (a dummy treatment that looks the same but has no active ingredients). Researchers will carefully monitor any side effects and changes in the cancer, such as its size and how cells are shed into the urine. They'll also examine tissue samples from surgery. The main goal is to understand if Alpha1H can reduce the size of bladder tumours or make them respond positively before surgical removal, and to ensure it's well-tolerated.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Hamlet BioPharma AB

Enrolment target

Start

09 Jan 2025

Non-muscle invasive bladder cancer awaiting transurethral surgery

What is this study about?

This study is looking into a new treatment called Alpha1H for a type of bladder cancer that hasn’t spread deep into the bladder wall. This is often called non-muscle invasive bladder cancer. People taking part in this study are all waiting to have surgery to remove their tumour, which is a common treatment for this type of cancer.

The main aim of the study is to check if Alpha1H is safe for people to use and if it causes any unwanted side effects. We also want to see if this new treatment can have a positive effect on the cancer before surgery. This might mean making the tumour smaller, changing its shape, or even encouraging cancer cells to be shed into the urine, which could be a sign that the treatment is working. Some people in the study will receive Alpha1H, while others will get a placebo, which looks identical but doesn't contain any active medicine. This helps researchers fairly compare how well Alpha1H works.

Researchers will be looking at several things. They’ll keep a close eye on any side effects you might experience. They’ll also check your vital signs like blood pressure, do heart traces (ECGs), and take blood tests. They will collect urine samples to look for cancer cells being shed and examine your bladder using a small camera (cystoscopy) to see how the tumour is responding. After surgery, the removed tumour will be carefully examined in the lab to understand the effects of Alpha1H on the cancer tissue.

Key takeaways

This study is for adults with early bladder cancer awaiting surgery.
It tests a new treatment, Alpha1H, for safety and effectiveness.
Some participants will receive Alpha1H, others a dummy treatment (placebo).
Doctors will monitor side effects and how the tumour changes before surgery.
Participation involves hospital visits, tests, and follow-up after surgery.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. There is no upper age limit. Both men and women are welcome to take part.

You would need to have been diagnosed with non-muscle invasive bladder cancer and be scheduled for surgery to remove the tumour. The doctors running the study will check if your specific health situation and type of bladder cancer match what they are looking for to make sure the study is right and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with non-muscle invasive bladder cancer?
Are you waiting for surgery (transurethral surgery) for your bladder cancer?
Are you able to attend regular hospital appointments for check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either receive the Alpha1H treatment or a placebo. This means you won’t get to choose which one you receive, and neither will your doctor. During the study, you'll have regular hospital visits for assessments. These will include checking your vital signs (like blood pressure and heart rate), having ECGs (heart traces), and giving blood and urine samples. Doctors will also examine your bladder using a cystoscope – a thin, flexible tube with a camera – to see how your tumour is responding. After your surgery to remove the tumour, there will be a follow-up period for about 30 days to monitor any side effects. The total duration of your active involvement in the study, including treatment and immediate follow-up, will be relatively short, leading up to and just after your planned bladder surgery.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of receiving a new treatment that isn’t yet widely available, and it helps advance medical knowledge. However, there are potential risks, including side effects from the medication, which could range from mild to more serious, even if the treatment is mainly focused on safety. It's important to remember that Alpha1H might not benefit everyone, or it might not work at all. You will be closely monitored by medical staff throughout the trial, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Czechia

Common questions

What is 'non-muscle invasive bladder cancer'?

It's an early form of bladder cancer where the cancer cells are only in the lining of the bladder and haven't spread into the deeper muscle layer.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the new treatment fairly.

Why is the study looking at 'cell shedding' in urine?

Researchers believe that if the Alpha1H treatment is working, it might cause cancer cells to be shed into the urine, which could be an early sign of tumour response.

Will I know if I'm getting Alpha1H or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you are receiving Alpha1H or the placebo until after the study is complete, unless there's a medical need to find out.

What is a 'cystoscopy'?

A cystoscopy is a procedure where a doctor uses a thin, flexible tube with a camera to look inside your bladder to check on the tumour.