A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)
This important study, called CodeBreaK 100, is looking at a new drug called Sotorasib (also known as AMG 510) for people with advanced solid tumours, particularly those with a specific genetic change called KRAS p.G12C. This genetic change can make cancer grow and spread. The study is in two early stages (Phase 1 and Phase 2), which means it's one of the first times this drug is being widely given to people. Researchers are carefully checking if Sotorasib is safe, what side effects it might cause, how the body handles the drug, and if it helps to slow down or shrink the cancer when used alone or with other medicines, especially for a type of lung cancer called NSCLC.
At a glance
What is this study about?
This research study, known as CodeBreaK 100, is designed to investigate a new medication called Sotorasib (also known by its research name, AMG 510). It's for people who have advanced solid tumours, which means cancers that have grown or spread. What makes this study special is that it focuses on cancers that have a specific change in their genes called KRAS p.G12C. This genetic change is like a switch that can tell cancer cells to grow, and Sotorasib is designed to block this switch.
The study is in its early stages (Phase 1 and Phase 2). In Phase 1, the main goal is to find out if the drug is safe, what dose works best, and what side effects people might experience. Researchers will also look at how the body processes the medication. In Phase 2, they will continue to check safety, but also start to see how effective the drug is at helping with the cancer, for example, if it can shrink tumours or stop them from growing. The study looks at Sotorasib on its own and in combination with another widely used cancer treatment, particularly for a type of lung cancer.
Understanding how Sotorasib works could be a big step forward for people with these specific types of cancer. By carefully studying its effects, researchers hope to develop new and more effective ways to treat difficult cancers that have this particular genetic signature.
Key takeaways
- This study is for advanced solid tumours with a specific genetic change (KRAS p.G12C).
- It's testing a new drug, Sotorasib, alone and with other treatments.
- The main goals are to check the drug's safety, side effects, and how well it works.
- Regular health checks, scans, and blood tests will be part of the process.
- Participants must be 18 years or older and have the specific genetic change.
- You can discuss with your doctor if this study might be suitable for you.
Who may be eligible?
To be considered for this study, individuals must be at least 18 years old. Both men and women are welcome to take part.
Crucially, you would need to have been diagnosed with an advanced solid tumour that has a specific genetic change called KRAS p.G12C. This means your cancer would have been tested and shown to have this particular genetic marker. Your medical team can tell you if your cancer has this specific change.
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 diagnosis of an advanced solid tumour (cancer)?
- Has your cancer been tested and confirmed to have the KRAS p.G12C genetic change?
- Are you able to attend regular hospital or clinic visits?
What does participation involve?
If you join this study, you will receive the study medication, Sotorasib. You will have regular visits to the clinic, which will involve detailed health checks, physical examinations, and blood tests. You will also have heart scans (ECGs) and detailed body scans like CT or MRI scans at specific times to see how the cancer is responding to the treatment. The research team will closely monitor you for any side effects and overall changes in your health. The total duration of your participation will depend on how you respond to the treatment and the phase of the study you are in, but it will involve ongoing assessments as long as you are receiving the study drug.
Potential risks and benefits
Locations (8)
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- —UnverifiedAustria
- —UnverifiedGreece
Common questions
What is the KRAS p.G12C genetic change?
It's a specific alteration in a gene that can sometimes make cancer cells grow and spread. This study is for people whose cancer has this particular change.
What does 'advanced solid tumours' mean?
This means your cancer is a solid lump (not a blood cancer) that has grown beyond its original site or has spread to other parts of your body.
What is Sotorasib?
Sotorasib is a new experimental drug in tablet form that aims to block the effects of the KRAS p.G12C genetic change, potentially stopping cancer growth.
What are Phase 1 and Phase 2 studies?
These are early stages of drug development. Phase 1 mainly checks safety and best dose, while Phase 2 further examines safety and how well the drug works against the cancer.
Will I get this medicine for free if I join?
Yes, if you meet the study requirements and choose to participate, the study drug will be provided to you as part of the research.
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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