Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Phase 1 study of NG-641 plus nivolumab (or standard of care PD-1) in metastatic or advanced epithelial tumours (NEBULA)

This research study is for people in the UK who have advanced or spreading epithelial tumours, which are common types of cancer that start in the lining of organs. It's a 'Phase 1' study, meaning it's one of the first times this new treatment, called NG-641, is being given to people. Researchers will give NG-641 alongside another cancer medicine that is already available, such as nivolumab. The main aim is to check if this new combination of treatments is safe and to see how the body reacts to it. They will also look for early signs of how well it might work. This type of early trial helps doctors understand new medicines before they can be tested more widely.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Akamis Bio Limited

Enrolment target

Start

23 May 2023

Metastatic cancer, Epithelial tumours

What is this study about?

This study is called NEBULA, and it's looking into a new way to treat certain advanced cancers. When we say 'advanced epithelial tumours', we're talking about cancers that have spread from where they started, and that began in the tissues that line organs and surfaces of your body, like your skin, lungs, or bowel. The study is testing a new medicine, NG-641, which will be given together with a type of existing cancer drug called a PD-1 inhibitor (like nivolumab). These PD-1 inhibitors work by helping your immune system fight cancer.

Because this is a 'Phase 1' study, it's very much focused on getting to know the new treatment. This means the doctors will be carefully watching to see if NG-641 is safe when given with the other medicine, and what dose might be best. They'll also be looking at how the new medicine behaves in the body – for example, how it's absorbed and how long it stays in your system. While the main goal isn't to see how well it treats cancer at this stage, they will also be looking for any early signs that it might be effective.

The overall aim of this kind of research is to find new and better ways to treat cancer. By taking part in a Phase 1 study, you could be helping doctors learn more about potential future treatments that could one day benefit many people. It’s an important step in developing new medicines.

Key takeaways

This is an early-stage UK study for advanced or spreading cancer.
It tests a new medicine (NG-641) combined with an existing one (nivolumab or similar).
The main focus is on safety and understanding how the new treatment works in the body.
Participants must be 18 or older with specific types of advanced cancer.
Taking part involves regular hospital visits for treatment and monitoring.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. There is no upper age limit mentioned, so older adults can also be considered.

This study is for people who have been diagnosed with advanced or spreading cancer, specifically 'epithelial tumours'. This means cancers that have developed from the cells that line the surfaces of your body, such as skin, lung, breast, prostate, or bowel cancer, which has also spread to other parts of the body.

Both men and women can join this study. Other specific health requirements would be detailed by the study doctors to make sure it's safe for you to take part.

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?
Do you have a diagnosis of advanced or spreading cancer?
Is your cancer an 'epithelial tumour' type?
Are you able to travel to a study site for regular appointments?
Are you willing to potentially receive a new, investigative treatment?

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 NG-641 along with nivolumab or a similar standard treatment. You would have regular visits to the hospital or clinic to have blood tests, scans, and other checks to see how you are responding to the treatment and to monitor for any side effects. You might need to fill out questionnaires about how you are feeling.

The exact number of visits and the full length of the treatment will depend on how you respond and what the doctors decide is best for your care. After the main treatment, there would likely be a follow-up period where doctors continue to check on your health and any effects of the treatment, even if you stop taking the study medicines. The total duration of your involvement could range from several months to possibly longer, depending on the study plan.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. You might benefit from receiving a new treatment that isn't widely available, which could potentially help your cancer. However, as this is an early-stage study, the main goal is to understand safety, and it's not guaranteed that the treatment will help your cancer. There's always a risk of side effects from the new medicine, which could range from mild to serious, or even side effects that are not yet known. The study team will explain all known risks to you. 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
Belgium
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Unverified
Spain

Common questions

What is a 'Phase 1' study?

A Phase 1 study is a very early stage of research where doctors test a new medicine in a small group of people for the first time. The main goal is to check if it's safe and to find the right dose, rather than to confirm how well it works.

What are 'epithelial tumours'?

Epithelial tumours are cancers that start in the cells that line the surfaces of your body, like your skin, or the inside of organs such as your lungs, stomach, or bowel.

What is nivolumab?

Nivolumab is a type of cancer medicine, already approved for use, that works by helping your body's immune system recognise and fight cancer cells.

Will I definitely get better if I join this trial?

No, there's no guarantee the treatment will make you better. This study is mainly focused on checking the safety of the new medicine and how the body reacts to it, rather than being a guaranteed treatment.

Can I stop taking part if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your standard medical care.