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

Phase 1 study of NG-350A plus pembrolizumab in metastatic or advanced epithelial tumours (FORTIFY)

The FORTIFY study is a new clinical trial looking into a potential treatment for advanced or metastatic epithelial tumours. These are cancers that have grown or spread from the cells lining the surfaces of organs, like the skin, lungs, or bowel. The study is testing a new investigational drug called NG-350A, given alongside another cancer medicine called pembrolizumab, which is already used to treat some cancers. This is an early-stage study, meaning it's primarily designed to find out if the new treatment combination is safe and what dose works best. It also aims to see if there are any early signs that the treatment might be effective. Participants will be adults aged 18 and over, and both men and women can take part. The study hopes to offer new possibilities for people living with these types of advanced cancers.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Akamis Bio Limited

Enrolment target

Start

12 Jun 2023

Epithelial tumours, Metastatic cancer

What is this study about?

This research study, called FORTIFY, is for people who have advanced cancer. When we say 'advanced cancer,' it means the cancer has either grown significantly or spread to other parts of the body. The specific type of cancer this study is looking at is called 'epithelial tumours.' These are cancers that start in the cells that form the lining of surfaces in your body, such as your skin, the lining of your digestive system, or the lining of your lungs. This is a common type of cancer.

The study aims to test a new medicine, which we're calling NG-350A, in combination with a drug that is already approved for cancer treatment, known as pembrolizumab. Pembrolizumab works by helping your body's immune system fight the cancer. Researchers want to find out how these two treatments work together. This is a 'Phase 1' study, which means it's one of the first times this new combination is being tested in people. The main goals are to make sure the treatment is safe, to understand any side effects, and to find the best dose to give.

While safety is the main focus, the study will also look for early signs that the treatment might be helping to shrink the cancer or slow its growth. If these early trials show promise, the treatment could move into larger studies to confirm its effectiveness. The hope is that this research will lead to new and better ways to treat advanced epithelial tumours in the future, offering more options for patients.

Key takeaways

This study is testing a new combination treatment for advanced epithelial cancers.
It's an early-stage study (Phase 1) focused on safety and finding the best dose.
The new drug (NG-350A) is combined with an existing cancer drug (pembrolizumab).
It's open to adults aged 18 and over, both men and women.
Participation involves regular hospital visits for treatment and monitoring.
You can stop participating at any time.

Who may be eligible?

To join any clinical study, there are certain rules about who can take part. These rules, called 'eligibility criteria,' help make sure the study is safe for everyone involved and that the results are clear.

For the FORTIFY study, people can only take part if they are 18 years old or older – there's no upper age limit. The study is open to both men and women. You must have an 'epithelial tumour' that is considered 'advanced' or has 'metastasised.' This means the cancer has either grown significantly or spread from where it started to other parts of your body.

While the exact details aren't listed here, typically, other rules would apply. For example, you would usually need to be healthy enough to undergo the treatments, have a certain level of organ function (like your kidneys and liver), and might not be able to join if you've recently had certain other treatments or have other serious health conditions. Your doctor or the study team would go through all these details with 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 an epithelial tumour?
Has your cancer been described as 'advanced' or 'metastatic'?
Are you generally well enough to consider a new treatment?
Are you able to travel to a clinic for regular appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the FORTIFY study, you'll be giving an investigational new drug (NG-350A) in combination with pembrolizumab. This will involve regular visits to the hospital or clinic for your treatments and check-ups. The exact schedule will vary, but typically, you might have treatments every few weeks, and each visit could involve blood tests, physical examinations, and scans (like CT scans) to see how you're responding and to monitor your health.

You'll be carefully monitored for any side effects. The study team will need you to report any changes in your health, no matter how small they seem. The total time you'd spend in the study can vary. You might continue treatment as long as it's helping and you're not experiencing severe side effects. After your treatment period, there will usually be a follow-up period where the study team will continue to check on your health and well-being. All of this will be clearly explained in detail if you are considering joining.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. While there's no guarantee the treatment will help, it might shrink your cancer or slow its growth. However, all medical treatments carry risks. You might experience side effects from the study drugs, some of which could be serious or unexpected. These will be thoroughly explained to you, but not all risks are known in early-stage trials. Remember, you have the right 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 an 'epithelial tumour'?

It's a type of cancer that starts in the cells lining the surfaces of your body, like skin, or the inside of organs such as the lungs or stomach.

What does 'advanced' or 'metastatic' cancer mean?

It means the cancer has grown considerably or has spread from where it started to other parts of your body.

What is a 'Phase 1' study?

It's an early safety study to see how a new treatment works in people, find the right dose, and check for side effects. It's not primarily about how effective it is yet.

What is pembrolizumab?

Pembrolizumab is a cancer drug already approved for use. It works by helping your body's immune system fight the cancer.

Will this study cure my cancer?

This early-stage study is primarily focused on safety and finding the right dose. While we hope for positive effects, it's not designed to be a cure, and there's no guarantee it will help your cancer shrink or stop growing.