Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

An open-label Phase 1 study of NEO-PTC-01 in patients with advanced or metastatic melanoma

This is an early-stage research study, called a Phase 1 trial, for a new medicine named NEO-PTC-01. It's for adults who have a type of skin cancer called melanoma that has spread to other parts of the body (metastatic melanoma). The main goal of this first study in humans is to find out if NEO-PTC-01 is safe to use and how the body handles it. Researchers will also be looking to see if there are any signs that the medicine could help treat the cancer. It's an 'open-label' study, meaning everyone involved will know they are receiving the study medicine. This research is a crucial step in seeing if this new treatment could eventually become an option for patients with advanced melanoma.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Biontech US Inc.

Enrolment target

Start

19 Dec 2023

Metastatic melanoma

What is this study about?

This study is an early look at a new medicine, called NEO-PTC-01, for people diagnosed with melanoma that has spread to other parts of their body. Melanoma is a serious type of skin cancer, and when it spreads, it's called metastatic melanoma. Finding new ways to treat this condition is very important.

Because this is a very early study (a Phase 1 trial), its main purpose is to see if NEO-PTC-01 is safe for people to take and to understand how the body processes it. Researchers will carefully check for any side effects and learn about the right dose. They will also be looking for any signs that the medicine might be helping to slow down or shrink the cancer, though helping with the cancer itself isn't the main goal of this very first study.

By taking part, individuals would be helping doctors and scientists learn more about this potential new medicine. This kind of research is vital because it lays the groundwork for developing new treatments that could benefit many patients in the future. It helps us understand if NEO-PTC-01 is promising enough to be studied further in larger groups of people.

Key takeaways

This is an early study for a new melanoma medicine.
It's for adults with melanoma that has spread (metastatic).
The main goal is to check if the medicine is safe.
You'll know if you're getting the study medicine.
Participation involves regular clinic visits and tests.
You can stop participating at any time.

Who may be eligible?

This study is for adults age 18 and older. It doesn't matter if you are male or female; anyone can potentially join. The main medical requirement is that you have metastatic melanoma, which means your melanoma has spread to other parts of your body.

There might be other health conditions or previous treatments that could mean you can't join, as studies need to be very careful to keep participants safe and get clear results. For example, if you have certain other serious health problems, the researchers might decide it's not safe for you to take part at this early stage.

It's important to have a full discussion with your doctor who knows your medical history to see if this study, or any other, is right for you. They can help you understand all the requirements.

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 metastatic melanoma (melanoma that has spread)?
Are you willing and able to attend regular clinic appointments and tests?
Are you able to understand and sign the consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given the new medicine, NEO-PTC-01. Because this is an 'open-label' study, you and your doctors will know you are receiving the study medicine. You would have regular visits to the clinic so the study team can carefully monitor your health. These visits would involve various assessments, such as blood tests, urine tests, and possibly scans to see how your body is reacting to the medicine and to check on your cancer.

The doctors and nurses would ask you about any side effects you might be experiencing. These visits are essential for making sure the medicine is safe and to understand how it's working. The total duration of your participation would depend on how your body responds to the medicine and the study plan, but it would involve a period of receiving the medicine and then follow-up appointments.

Potential risks and benefits

Participating in any medical study has both potential benefits and risks. A potential benefit could be access to a new medicine not yet widely available, which might help your condition, although this is not guaranteed, especially in early studies. You would also be closely monitored by a team of healthcare professionals. Possible risks include experiencing side effects from the new medicine, which could be mild or more serious, and there's no guarantee the medicine will help your melanoma. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Netherlands
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Unverified
Belgium
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Unverified
Spain

Common questions

What does 'Phase 1 study' mean?

It means this is the very first time this new medicine is being tested in humans. The main goal is to check for safety and find the right dose.

What is 'metastatic melanoma'?

It's a type of skin cancer that has spread from where it started to other parts of the body.

Will I definitely get the new medicine?

Yes, in this 'open-label' study, all participants receive the study medicine, NEO-PTC-01.

What kind of tests will I have?

You'll have regular checks like blood tests, urine tests, and possibly scans to monitor your health and how the medicine is working.

Can I stop being part of the study?

Yes, you are free to leave the study at any time, and it won't affect your regular medical care.