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

A study to evaluate the safety, tolerability and distribution of TB0010 in head and neck squamous cell carcinoma

This is an early-stage study, meaning it's one of the first times this new medicine, called TB0010, is being given to people. The main goal is to check how safe it is and if patients can cope with any side effects. Doctors also want to understand how the medicine travels and works inside the body. This study is specifically for adults who have a type of head and neck cancer that has a particular marker called EGFR-Positive. It’s an important first step in understanding if TB0010 could be a helpful future treatment option.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Tenboron Oy

Enrolment target

Start

22 Oct 2024

EGFR-Positive Head and Neck Squamous Cell Carcinoma

What is this study about?

This study is about a new medicine called TB0010, which is being tested for the first time in people. It's designed for a type of cancer that starts in the head and neck area. Specifically, it's for head and neck squamous cell carcinoma, and only for those cancers that show a certain characteristic called "EGFR-Positive". This means the cancer cells have a particular protein on their surface that the new medicine might target.

The main aim of this first study is to find out if TB0010 is safe to give to people and to see what side effects people might experience. It's very common for new medicines to go through these early safety checks before they can be tested further. Researchers will also be looking at how the medicine is absorbed, distributed, and removed from the body.

Understanding these basic things about a new medicine is a crucial first step. If TB0010 is found to be safe and well-tolerated, it could then move on to bigger studies to see how well it actually treats the cancer. This kind of research helps doctors find new ways to fight cancer in the future.

Key takeaways

This is an early study testing a new medicine called TB0010.
It's for a specific type of head and neck cancer (EGFR-Positive).
The main goal is to check how safe the medicine is.
Participants will receive the new medicine and have regular check-ups.
Your involvement could help doctors find future treatments for cancer.

Who may be eligible?

This study is for adults diagnosed with a specific type of head and neck cancer. Your doctors will need to check if your cancer has a particular feature called "EGFR-Positive." This is an important detail that makes your cancer suitable for this specific treatment.

To join, you must be at least 18 years old. There is no upper age limit, meaning older adults can also be considered. Both men and women are welcome to take part if they meet all the other requirements.

Your cancer care team will review all your health information and conduct some tests to confirm if you are a good fit for this study. They will be able to tell you exactly if your medical situation matches the study's needs.

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 head and neck squamous cell carcinoma?
Has your doctor confirmed your cancer is 'EGFR-Positive'?
Are you able to attend regular clinic appointments and tests?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic so doctors can give you the new medicine (TB0010) and check your health. You would also have different tests, such as blood tests, scans, and possibly other medical examinations, to see how the medicine is affecting your body and the cancer. These tests help the doctors understand if the medicine is safe and how it's working.

There will be a set schedule for these visits and tests throughout the study. After you stop taking the medicine, there will usually be some follow-up appointments to monitor your health. The total time you spend in the study will depend on the study plan, but your doctor can give you a clear timeline.

Potential risks and benefits

While we hope this study might lead to new treatments, it's important to know that as this is a very early study, the main goal is to understand the medicine's safety, not necessarily to treat your cancer immediately. You might not experience direct health benefits yourself. However, your participation will provide valuable information that could help others in the future. As with any new medicine, there's a risk of side effects, which could be mild or more serious. The doctors will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Finland

Common questions

What does 'EGFR-Positive' mean?

It means your cancer cells have a specific protein called EGFR on their surface. This study medicine is designed to target this particular protein.

Will I definitely get the new medicine?

Yes, if you join this study, everyone will receive the new medicine called TB0010, as it's testing its safety for the first time in people.

What kind of tests will I have?

You'll likely have blood tests, scans (like CT or MRI), and regular check-ups to monitor your health and see how your body is reacting to the medicine.

How long will I be in the study?

The exact duration can vary, but your study team will explain the full schedule of treatments and follow-up appointments when you discuss joining.

What if I change my mind about participating?

You are free to leave the study at any point, for any reason. Your decision will not affect your future medical care.