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

A Phase 1 Study of TAS0612 in Patients with Locally Advanced or Metastatic Solid Tumors

This is a very early-stage study, called a Phase 1 trial, for adults with advanced solid cancers that have either grown into nearby tissues (locally advanced) or spread to other parts of the body (metastatic). The new medicine being tested is called TAS0612. It's the first time this medicine is being given to people. Researchers want to find out if TAS0612 is safe to use and what dose is best. They will also look at how the body handles the medicine. While not the main goal, they will also keep an eye on any effects the medicine might have on the cancer. This kind of study is crucial for learning about new treatments before they can be tested more widely.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Taiho Oncology Inc.

Enrolment target

Start

02 Oct 2024

Locally Advanced or Metastatic Solid Tumors

What is this study about?

Imagine scientists have developed a brand new key and they think it might unlock a way to help with certain types of cancer. This study, called a clinical trial, is the very first time they are trying that new key, a medicine called TAS0612, in people. It’s like testing a prototype to see if it works as expected and if it's safe to handle.

This trial is for adults who have what doctors call 'solid tumours' – that's cancer that forms a lump, rather than liquid cancers like leukaemia. These cancers are either 'locally advanced,' meaning they've grown quite a bit in the area where they started, or 'metastatic,' which means the cancer cells have spread from where they began to other parts of the body.

The main aim of this early study isn't to cure the cancer, but to gather important information. The researchers want to carefully check if TAS0612 is safe for people to take and to figure out the right amount (dose) that can be given without causing too many problems. They will also learn how the body deals with the medicine. This vital first step helps decide if the medicine is promising enough to continue testing in larger studies, which is how all new treatments eventually become available.

Key takeaways

It's a very early study (Phase 1) testing a new cancer medicine called TAS0612.
The main aims are to check safety and find the right dose, rather than to treat cancer directly.
It's for adults with advanced solid cancers that have spread or grown locally.
Participants will be closely watched for side effects and how their body handles the medicine.
You have the right to leave the study at any time.
It's a chance to contribute to developing future cancer treatments.

Who may be eligible?

This study is looking for adults aged 18 years and older. There is no upper age limit. It includes both men and women.

To be considered, you must have a solid tumour – which means a type of cancer that forms a lump, like breast cancer or lung cancer, rather than a blood cancer. This cancer should be either locally advanced, meaning it has grown significantly in its original area, or metastatic, meaning it has spread to other parts of your body. We don't have all the details here about specific types of cancer, or other health conditions that might prevent you from joining.

It's important to remember that these trials have very specific rules about who can take part to make sure the study is safe and that the results are clear. Your doctor will need to check your medical history and do some tests to see if this study is right for 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?
Do you have a type of cancer that forms a lump (a solid tumour)?
Has your cancer either grown into nearby tissues (locally advanced) or spread to other parts of your body (metastatic)?
Are you able to attend frequent hospital visits and tests?

Answer every question to see your result.

What does participation involve?

As this is a very early study (Phase 1), taking part would likely involve frequent hospital visits, especially in the beginning. You would receive the new medicine, TAS0612, which might be given in different ways, such as tablets or injections, but this isn't specified here. Researchers would monitor you very closely for any side effects and to see how your body handles the medicine. This would involve regular blood tests, check-ups, and possibly scans.

The total duration of your participation would depend on how your body responds to the medicine and the study's design, but early phase trials often involve regular follow-ups over several months. You would be expected to attend all scheduled appointments and report any changes in your health to the study team.

Potential risks and benefits

Participating in a study like this might offer a potential benefit if the new medicine, TAS0612, happens to have a positive effect on your cancer, although this is not the main goal of this early phase. There's also the benefit of contributing to medical science, which could help future patients. However, there are potential risks, as TAS0612 is a new medicine being given to humans for the first time, and its side effects are not fully known. You might experience unexpected or unpleasant side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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
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Unverified
France
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Unverified
Italy

Common questions

What does 'solid tumours' mean?

Solid tumours are cancers that form a lump or mass, like breast cancer, lung cancer, or bowel cancer, rather than blood cancers like leukaemia.

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

'Locally advanced' means the cancer has grown into nearby tissues, while 'metastatic' means it has spread from where it started to other parts of the body.

What is a 'Phase 1' study?

A Phase 1 study is the very first time a new medicine is given to humans. Its main purpose is to check for safety and find the best dose, not primarily to treat the disease.

Will this medicine cure my cancer?

The main goal of this early study is to find out if the medicine is safe and what dose is best. While researchers will monitor your cancer, treating it is not the primary aim of a Phase 1 trial. We don't know yet if it can cure cancer.

Will I get a placebo (dummy treatment)?

In a Phase 1 study like this, it's very unlikely you would receive a placebo. Most participants will receive the active new medicine, TAS0612, at different doses.