A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer
This research study is investigating a new medication called TAK-280. It's designed for individuals battling advanced cancer that has spread or cannot be surgically removed. This is an early-stage study, meaning it's one of the first times this drug is being tested in people. The main goals are to carefully check for any side effects and find the safest dose of TAK-280. Researchers will also be monitoring how the body absorbs, uses, and gets rid of the drug, and will look for any signs that the cancer is responding to the treatment. This trial aims to gather important information to help understand if TAK-280 could be a helpful treatment option in the future. The study involves continuous monitoring over several months to ensure participant safety and collect detailed information.
At a glance
What is this study about?
This clinical trial is designed to investigate a new medication called TAK-280 for people who have advanced cancer that either can't be removed with surgery or has spread to other parts of the body. This kind of cancer is often called ‘unresectable locally advanced or metastatic cancer’. The study is an early-stage trial, which means it's among the first times this specific drug is being given to human volunteers. This is a crucial step in developing new treatments, as it helps doctors understand how a new medicine works in people.
The main purpose of this study is to find out if TAK-280 is safe and what side effects it might cause. Researchers will start with a very low dose and slowly increase it, carefully watching each participant. This process is called 'dose-escalation' and helps them find the safest and most effective amount of the drug. They will also be looking closely at how the body handles TAK-280 – for example, how much of it gets into the blood and how quickly the body gets rid of it. This information is key to understanding how the drug behaves.
While safety is the top priority, the researchers will also be checking to see if TAK-280 has any positive effects on the cancer. This includes looking for signs that the cancer has stopped growing or has even shrunk. Medications like siltuximab and tocilizumab might also be used in some cases, possibly to help manage certain side effects that could occur. By gathering all this information, the study aims to determine if TAK-280 has the potential to become a beneficial treatment option for patients with advanced cancer in the future.
Key takeaways
- This study is testing a new drug, TAK-280, for advanced cancer.
- It's an early-stage study primarily focused on safety and side effects.
- Researchers will also track how the body processes the medication.
- The study looks for signs of the cancer responding to treatment.
- Participation could last up to 37 months with regular clinic visits.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old – there's no upper age limit. Doctors will carefully review your medical history and current health to make sure this study is right for you and that you meet all the necessary requirements.
Since this study focuses on advanced cancer that hasn't responded well to other treatments or can't be removed with surgery, your specific type and stage of cancer will be important. The study team will need to confirm that your cancer fits the criteria outlined for the research.
It's important to remember that participating in a clinical trial involves specific health checks and tests. The study team will explain everything clearly and answer any questions you have about what's involved and whether this study is suitable for your individual situation.
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 cancer that has spread or cannot be removed by surgery?
- Are you able to attend regular clinic visits and appointments?
- Are you willing to have blood tests and other assessments during the study?
What does participation involve?
If you decide to take part in this study, you'll be given the study medication, TAK-280. The amount you receive will be carefully decided by the study doctors, starting with a low dose and potentially increasing it over time. The study will involve regular visits to the clinic for assessments and check-ups. During these visits, you'll have blood tests to see how your body is reacting to the medicine and how much of the drug is in your system. You might also have scans or other tests to monitor your cancer.
The total participation in the study could last for up to 37 months, but individual treatment duration can vary. For the first month, doctors will be especially watchful for any significant side effects. Throughout the study, there will be frequent checks of your health, including blood samples taken at various times on specific days each cycle (for example, on Days 1, 2, 3, 8, 15, and 22). You will also have follow-up appointments even after you stop taking the study medication to monitor your well-being. The study team will provide a detailed schedule of visits and procedures if you are considering joining.
Potential risks and benefits
Locations (2)
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Common questions
What kind of cancer is this study for?
This study is for people with advanced cancer that cannot be removed by surgery or has spread to other parts of the body.
What is TAK-280?
TAK-280 is a new medicine being tested in this study to see if it can help treat advanced cancer. It's still in the early stages of development.
What does 'unresectable locally advanced or metastatic' mean?
It means the cancer has either grown too much locally to be surgically removed, or it has spread from where it started to other parts of your body.
What are the main goals of this study?
The main goals are to find out if TAK-280 is safe, what side effects it might cause, and how the body handles the drug. Researchers will also look for signs that it is helping to control the cancer.
Can I stop participating in the study if I want to?
Yes, you have the right to leave the study at any time, for any reason, without it affecting your routine 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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