Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

This research study is investigating a new medication, UGN-301, for adults in the UK who have non-muscle invasive bladder cancer (NMIBC) that has come back. NMIBC is a type of bladder cancer that has not spread very deeply into the bladder wall. This is a "Phase 1" study, which means it's one of the first times this new treatment is being tested in humans. The main goal is to find a safe dose of UGN-301 and understand how the body handles it. It will also look at any side effects and how well it might work. This early research is important for developing potential new ways to treat this condition.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Urogen Pharma Ltd.

Enrolment target

Start

11 Jul 2024

Non-muscle Invasive Bladder Cancer

What is this study about?

This study is for people who have a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This means the cancer is only in the inner lining of the bladder and hasn't gone deeper into the muscle. Sometimes, even after treatment, this type of cancer can come back. When it does, doctors look for new ways to treat it and stop it from returning or getting worse.

The study is testing a new medicine called UGN-301. Because it's a very early stage study (called 'Phase 1'), the main aim is to find the safest dose of UGN-301. Researchers will start with a very small dose and slowly increase it for different groups of patients, watching carefully for any side effects. They also want to understand how the body uses and gets rid of the medicine, and get an early idea of whether it could be helpful in treating the cancer.

Finding new and effective treatments for bladder cancer is really important. Studies like this help us learn more about potential new medicines. Even though this is an early study, the information gathered will help doctors decide if UGN-301 should be tested in larger studies in the future, hopefully leading to new options for patients.

Key takeaways

This study tests a new drug (UGN-301) for returning non-muscle invasive bladder cancer.
It's a very early-stage study (Phase 1) focused on finding a safe dose.
Participants will have regular medical checks and follow-up.
Potential benefits include access to a new treatment and helping research.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and have been diagnosed with non-muscle invasive bladder cancer that has come back.

There will also be other specific medical requirements that your doctors will check. For example, they will need to make sure your overall health is good enough to take part in the study and that you don't have certain other health conditions that might make the new treatment unsafe for you. They will also need to check what other treatments you might have had in the past.

Before you can join, the study doctors will review all your medical information carefully to make sure this study is right for you. They will explain everything in detail if you are interested.

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?
Has your bladder cancer come back after previous treatment?
Are you able to travel to study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, UGN-301, as directed by the study team. You would have regular visits to the hospital or clinic to see the study doctors and nurses. During these visits, you would have medical checks, which might include blood tests, urine tests, and possibly scans or procedures to check on your bladder cancer. These checks are important to see how the treatment is working and to monitor your health.

The study team will track any side effects you might experience and will be available to answer your questions. The total length of your participation, including follow-up appointments after you stop taking the treatment, will be explained fully by the study team. You will be told how often you need to visit and for how long.

Potential risks and benefits

Potential benefits of joining this study include getting early access to a new treatment that might help control your bladder cancer, especially if other treatments haven't worked well for you. You would also be contributing to medical research that could help many other patients in the future. However, as with any new medicine, there are potential risks and side effects that are not yet fully known. The study team will explain all known or expected risks. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Italy
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Unverified
Spain

Common questions

What is 'Phase 1' of a study?

Phase 1 means it's one of the first times a new drug is tested in humans. The main goal is to find a safe dose and look for any serious side effects.

What is NMIBC?

NMIBC stands for non-muscle invasive bladder cancer. This is bladder cancer that is only in the inner lining of the bladder and has not grown into the muscle layer.

Will this new treatment cure my cancer?

It's too early to say if UGN-301 will cure cancer. This study is mainly to find a safe dose and see how the body reacts to it. We hope it may help control the cancer.

Will I have to pay to be in the study?

No, all study-related treatments, tests, and care are provided free of charge if you take part in a clinical trial in the UK.

Who is running this study?

This study is being run by a company called UroGen Pharma Ltd. The study will take place in hospitals and clinics in the UK.