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

A phase I of TG6050 in the treatment of patients with metastatic lung cancer

This clinical trial is exploring a new medicine named TG6050 for patients who have a type of lung cancer called non-small cell lung cancer, which has spread to other parts of the body (metastatic). This is a 'Phase I' study, which means it's the very first time this new treatment is being given to people. Researchers want to carefully check if TG6050 is safe and to find the right amount (dose) that can be given. All adults aged 18 and over, regardless of their sex, could potentially take part. The main goal is to understand how the medicine works in the body and if it has any side effects before it can be studied further.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Transgene

Enrolment target

Start

03 Jul 2024

Non-small cell lung cancer (NSCLC)

What is this study about?

This study is about a new potential treatment called TG6050 for a type of lung cancer known as non-small cell lung cancer. This particular cancer is 'metastatic,' which means it has spread from where it started in the lung to other areas of the body. Finding new ways to treat cancer that has spread is very important, as current treatments don't always work for everyone.

This is a 'Phase I' study, which is the very first step in testing a new medicine in people. Think of it like a first careful test drive. At this stage, doctors are not yet trying to prove if the medicine can cure cancer. Instead, they are mainly focused on two things: making sure the treatment is safe for people to take, and figuring out the best dose. They'll start with small doses and gradually increase them, keeping a close eye on how patients react.

The overall aim of this early research is to gather initial information about TG6050. This includes how it behaves in the body, what dose is safe, and what side effects it might cause. This vital information will help decide if TG6050 is promising enough to be studied in larger groups of people in the future.

Key takeaways

This study is testing a new treatment (TG6050) for advanced lung cancer.
It's a very early 'Phase I' study to check safety and find the right dose.
It's for adults (18+) with non-small cell lung cancer that has spread.
Participation involves regular visits and health checks.
You can stop participating at any time.
Your contribution could help future cancer treatments.

Who may be eligible?

This study is open to adults aged 18 years and over. Both men and women can take part. While the main requirement is having non-small cell lung cancer that has spread, there will be other important health checks to make sure the study is a good fit for you.

For example, doctors will need to make sure your general health is good enough to safely receive the new treatment. This usually involves checking your heart, kidneys, and liver, and making sure other medical conditions are well-managed. These checks are in place to keep you as safe as possible while taking 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.

Am I at least 18 years old?
Do I have non-small cell lung cancer that has spread?
Am I generally well enough to try a new treatment?
Are my other health conditions (if any) currently stable or well-managed?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you might have regular visits to the hospital or clinic. During these visits, doctors and nurses will monitor your health closely, give you the study medication (TG6050), and perform tests like blood samples, scans, and physical exams. These tests help them check how you're responding to the treatment and if there are any side effects. The total duration of your participation could vary, as these types of studies often involve ongoing monitoring for a period after you start the treatment. Specific details about visits and duration would be fully explained by the study team.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as gaining access to a new treatment not yet widely available, and helping advance medical research. However, new treatments can also have potential risks, including side effects that are not yet fully known. 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
France

Common questions

What does 'Phase I' mean?

It means this is the very first time the new treatment is being tested in people. Doctors are mainly checking if it's safe and finding the right dose.

What kind of cancer is this study for?

It's for a type of lung cancer called non-small cell lung cancer that has spread to other parts of the body.

Will this study cure my cancer?

Phase I studies are not designed to prove a cure. They are focused on safety and finding the best dose for future studies.

Who can join this study?

Adults aged 18 or older with metastatic non-small cell lung cancer can be considered, regardless of sex. Other health checks will also be important.

What if I want to stop participating?

You can leave the study at any time, for any reason, without it affecting your regular medical care.