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

A Study of TAS2940 in Participants With Locally Advanced or Metastatic Solid Tumor Cancer

This research is looking into a new medication, TAS2940, for individuals whose cancer has spread or is considered advanced. Specifically, it's for solid tumours that show particular changes in genes known as EGFR or HER2. These gene changes can sometimes make cancer cells grow more quickly. This is a very early study, called a Phase I trial. This means it's one of the first times this medicine is being given to people. The main goals are to understand how the medicine behaves in the body, which doses are best, and to check for any side effects. It's an important step in finding new ways to treat these types of cancers.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Taiho Oncology Inc.
Enrolment target
23
Start
18 Oct 2023

What is this study about?

This study is exploring a new potential cancer treatment called TAS2940. It's designed for people who have solid tumours (meaning cancers that form lumps, like lung, breast, or bowel cancer) that have either spread to other parts of the body (metastatic) or are locally advanced, meaning they've grown quite a bit in the area where they started. The specific focus is on cancers that show certain changes in genes called EGFR or HER2. These gene changes can act like a switch, encouraging cancer cells to grow and divide.

At this stage, the study is a 'Phase I' trial. Think of it as a very first step in testing a new medicine in people. Doctors want to see how TAS2940 is processed by the body, how much of it is needed to have an effect, and to make sure it's safe. It's a careful process, starting with small doses and slowly increasing them under close medical supervision.

The reason this research is so important is that it helps doctors find new and more effective ways to fight cancer. By understanding how TAS2940 works and if it's safe at this early stage, it can potentially pave the way for future studies and, eventually, new treatment options for people with these specific types of cancer. It's about gathering crucial information to advance cancer care.

Key takeaways

  • This study is testing a new cancer medicine called TAS2940.
  • It's for advanced solid tumours with specific EGFR or HER2 gene changes.
  • This is an early-stage (Phase I) study to check safety and dosage.
  • It's for adults aged 18 and over, with no upper age limit.
  • Participation involves regular clinic visits for checks and monitoring.
  • You can stop participating in the study at any time.

Who may be eligible?

This study is looking for adults aged 18 years and older. There is no upper age limit, meaning older adults are also welcome to participate if they meet other criteria.

To be considered for this study, you must have a solid tumour cancer. This means it's a cancer that forms a mass or lump, rather than a blood cancer like leukaemia. Additionally, your cancer needs to be either 'locally advanced' (meaning it has grown significantly in one area) or 'metastatic' (meaning it has spread from where it started to other parts of your body).

Crucially, your cancer must also have specific changes in certain genes, either EGFR and/or HER2. Doctors will be able to test for these gene changes in your tumour. These detailed requirements help ensure the medicine is tested in the right group of people for whom it might be most helpful. Both men and women are welcome 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.

  1. Are you 18 years old or older?
  2. Do you have a solid tumour cancer (not a blood cancer)?
  3. Has your cancer spread or is it locally advanced?
  4. Has your doctor told you that your cancer has specific EGFR or HER2 gene changes?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given the new medicine, TAS2940. Because this is an early-stage study, you would have regular visits to the clinic. These visits will involve detailed health checks, including physical examinations, blood tests to see how your body is reacting to the medicine, and scans to monitor your cancer. Exactly how often you'd need to visit and for how long will be explained by the study team, as it can depend on how you respond to the treatment. They will also keep a close eye on any side effects you might experience. The total length of your involvement will be clearly discussed before you make any decisions.

Potential risks and benefits

Participating in an early-stage study like this means that while there's a chance the new medicine, TAS2940, might help shrink your cancer or slow its growth, it's also possible it may not work for you. There could be side effects from the medicine, some of which might not be known yet, so your health will be closely monitored. You will be given all known information about potential risks. It's important to remember that joining a study is always your choice, and you are free to withdraw at any time without needing to give a reason, and this will not affect your standard medical care.

Locations (1)

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

Common questions

What does 'solid tumour' mean?

A solid tumour is a cancer that forms a lump or mass of tissue, as opposed to blood cancers like leukaemia.

What are EGFR and HER2?

These are special genes in your body. Sometimes, changes in these genes can make cancer cells grow more quickly. This study is for cancers that have these specific changes.

What does 'Phase I' study mean?

It means this is one of the very first times this new medicine is being tested in people. The main goals are to check its safety and find the right dose.

Will I definitely get the new medicine?

Yes, in this type of study, all participants who are eligible will receive the medicine being tested, TAS2940.

Can I stop being part of the study if I change my mind?

Absolutely, you are free to leave the study at any time, for any reason, and it won't affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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