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

A Phase 1 study to evaluate IK-930 in subjects with advanced solid tumors

This research study is an early step in testing a new treatment called IK-930. It's designed for people who have advanced cancer, meaning cancer that has spread or is hard to treat. The main goal of this first-phase study is to see if IK-930 is safe for people and to understand how it behaves in the body. Researchers will also look for any side effects and try to figure out the right dose to use in future studies. Because it's the first time this medicine is being given to humans, it's called a 'Human Pharmacology' study. It's an important part of developing potential new cancer treatments, but it's not yet known if it will help treat cancer.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Ikena Oncology Inc.
Enrolment target
31
Start
14 May 2024

What is this study about?

This study is an important first step in checking a new medicine called IK-930 that could potentially help people with advanced cancer. When we say 'advanced cancer,' we mean cancer that has spread to other parts of the body or is difficult to treat with standard methods. The main purpose of this study is to carefully give IK-930 to a small number of people for the very first time ever. This is so doctors can see if it's safe, how their bodies react to it, and if there are any side effects. Think of it like taking a brand new car for its first test drive – the manufacturer wants to see how it performs before more people try it.

This kind of research is called a 'Phase 1' study. It's not primarily about treating the cancer itself yet, but rather about gathering crucial information on safety and dosage. Researchers will start with a very small amount of the medicine and slowly increase it, while watching the participants very closely. This helps them find a dose that is safe enough to test in larger groups of people later on.

Finding new treatments for cancer is a long and careful process. Studies like this one are vital because they lay the groundwork for understanding new medicines. While it's too early to know if IK-930 will become a successful cancer treatment, this study provides essential knowledge that could lead to new options for patients in the future. Your involvement in such a study, if you choose, contributes significantly to medical science.

Key takeaways

  • This is a very early study of a new medicine for advanced cancer.
  • The main goal is to find out if the medicine (IK-930) is safe and how it works in the body.
  • It's open to adults aged 18 and over, with advanced solid tumors.
  • Taking part means frequent check-ups and monitoring by a medical team.
  • Unknown risks are possible, but you can leave the study at any time.
  • Your participation helps to advance medical research.

Who may be eligible?

This study is looking for adults who are 18 years old or older. Both men and women can take part. The main requirement is that you have advanced cancer, which means your cancer has spread or is not responding well to other treatments.

Because this is an early study, there will be other specific health requirements to make sure it's safe for you to take part. For example, doctors will need to check your general health, recent blood tests, and other medical conditions. These checks help the medical team ensure your safety throughout the study.

It's very important to talk to your doctor and the study team. They will go through all the detailed requirements with you to see if this study is potentially a good fit 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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with advanced solid tumors?
  3. Are you willing to attend regular hospital visits for tests and monitoring?
  4. Are you able to understand and agree to the study requirements?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, IK-930. You would have regular visits to the clinic, which might include having blood tests, physical examinations, and scans to see how you are doing and how the medicine is affecting your body. These visits would be more frequent at the beginning of the study. The medical team would carefully monitor you for any side effects. You would also be asked to report how you are feeling throughout the study. The total duration of your participation would depend on how your body responds to the medicine and what the study doctors think is best for your care, as well as the study plan.

Potential risks and benefits

Potential benefits of taking part in this early study include contributing to medical science and potentially being among the first to receive a new experimental treatment. However, since this is the first time IK-930 is being given to people, the direct benefit to you is not known. There are potential risks, as with any new medicine. You might experience side effects, some of which could be mild, while others could be more serious or unexpected. The medical team will monitor you very closely for any problems. You will be given full information about known risks, and 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.
  • Unverified
    Netherlands
  • Unverified
    France
  • Unverified
    Spain
  • Unverified
    Italy

Common questions

What does 'advanced solid tumors' mean?

It means your cancer has spread to other parts of your body or is not responding well to standard treatments.

What is a 'Phase 1' study?

It's the very first stage where a new medicine is given to people. The main goal is to check if it's safe and how it acts in the body.

Will this medicine cure my cancer?

It's too early to know if IK-930 will treat cancer. This study is mainly focused on safety and understanding the medicine.

How long would I be in the study?

The length of time you'd be involved depends on your individual response and the study plan. The study team will explain this to you.

Can I stop being part of the study once I've started?

Yes, you can always choose to leave the study at any time, for any reason, and your medical care will not be affected.

How to find out more

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

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