A Phase 1 Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
This research study is for adults who have advanced solid cancers that have a particular gene change called 'KRASG12C'. We are testing a new combination of two medicines, INCB099280 and adagrasib, to see how well they work together. The main goals are to find out if the combination is safe and what side effects it might cause. We will also check if the medicines help to shrink the cancer or stop it from growing. This is an early-stage study, which means we are learning about these drugs for the first time in people, so it's important to understand the risks involved. Your doctor will be able to tell you more about whether this study might be right for you.
At a glance
What is this study about?
This study is looking at a new way to treat advanced solid cancers. 'Advanced' means the cancer has grown or spread, and 'solid tumors' means it's a lump of cancer found in organs like the lung or bowel, rather than blood cancers like leukaemia. Specifically, this study focuses on cancers that have a particular genetic fault called 'KRASG12C'. This fault is important because it can make cancer cells grow and spread.
The study is testing two medicines together: INCB099280 and adagrasib. Adagrasib is a medicine that's already approved for some KRASG12C cancers. INCB099280 is a newer medicine, and we want to see how it works in combination with adagrasib. By combining them, researchers hope to get a stronger effect against the cancer cells while keeping side effects manageable.
The main aim of this study is to understand the safety of this new combination. This involves carefully looking at any side effects people experience and how their bodies handle the medicines. Researchers will also be checking if the combination helps to shrink tumours or stop them from growing. This is an 'early phase' study, meaning it's one of the first times this specific combination is being tested in people. The information gathered will help decide if these medicines are promising enough to be studied in a larger group of patients in the future.
Key takeaways
- This study is for adults with advanced solid cancers having a 'KRASG12C' gene change.
- It tests a new combination of two medicines: INCB099280 and adagrasib.
- The main aims are to check safety and see if the medicines help control the cancer.
- Participation involves regular visits, taking medicines, and close monitoring for side effects.
- It's an early-stage study, so potential risks and benefits need to be discussed with your doctor.
Who may be eligible?
To join this study, you must be an adult, aged 18 or older. Both men and women can take part. The most important requirement is that you have been told you have an advanced solid cancer that has a specific gene change called 'KRASG12C'.
Your cancer must be advanced, meaning it has grown or spread, and it must be a solid tumour, not a blood cancer. Your doctor will need to perform tests to make sure your cancer has the 'KRASG12C' gene change. This is a very specific type of cancer, and not all cancers will have this particular change.
Your doctor will check other health information, like your general health, organ function, and any other medical conditions you might have, to make sure it's safe for you to take these new medicines. It's important to discuss your full medical history with your doctor to see if you meet all the requirements for this study.
- Are you 18 years old or older?
- Do you have a solid tumour (not a blood cancer)?
- Has your doctor told you your cancer is 'advanced' (grown or spread)?
- Has your cancer been tested and confirmed to have the 'KRASG12C' gene change?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would have blood tests, physical examinations, and scans to monitor your health and the cancer. You would also need to take the study medicines, INCB099280 and adagrasib, likely by mouth, as prescribed by the study team.
The study team will closely monitor you for any side effects and adjust your treatment if needed. This might involve pausing the medicine, changing the dose, or, in some cases, stopping the medicine permanently if side effects are too severe. The total duration of your participation would depend on how your body responds to the treatment and the effects on your cancer, as well as if you experience any side effects.
Potential risks and benefits
Locations (3)
- —Italy
- —France
- —Spain
Common questions
What is 'KRASG12C'?
It's a specific genetic change or 'fault' found in certain cancer cells that can make them grow and spread. This study is for cancers that have this particular change.
What does 'advanced solid tumors' mean?
It means the cancer is a solid lump, not a blood cancer, and it has grown or spread in the body.
Are these medicines approved for everyone?
Adagrasib is approved for some KRASG12C cancers, but INCB099280 is a newer medicine, and this study is looking at how they work together for the first time in people.
What is the main goal of this study?
The main goal is to find out how safe the combination of INCB099280 and adagrasib is, and what side effects it might cause. We also check if it helps control the cancer.
Can I stop participating if I want to?
Yes, you can choose 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.
Discussion
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