A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
This research study, called CodeBreaK 100, is for adults with advanced cancers that have a specific genetic change called KRAS p.G12C. This means the cancer has a particular fault in its genetic code. The study is testing a new treatment called sotorasib, which is designed to target this specific gene fault. The main goals are to check if the new medicine is safe, to find the best dose to give, and to see how well it works in people whose cancer has spread or is hard to treat. This trial is in its early stages (Phases 1 and 2), which means researchers are carefully learning about sotorasib's effects before it can be more widely used. They are also looking at how the body handles the medicine.
At a glance
What is this study about?
This study is a clinical trial, which means it’s a carefully planned research project involving people. It's designed to explore a new potential cancer treatment called sotorasib. The treatment is for adults whose cancer has grown or spread, and importantly, only for those whose cancer has a specific genetic alteration called the KRAS p.G12C mutation. This mutation is like a tiny error in the cancer cell's instruction manual that can make it grow and spread.
The main aims of this study are to understand sotorasib better. Firstly, the researchers want to make sure it's safe and that people can tolerate taking it. They will keep a close eye on any side effects. Secondly, they want to figure out the right amount, or dose, of sotorasib to give that is both safe and potentially effective. Finally, they will also look to see if this treatment can help to shrink or stop the growth of the cancer.
Finding new treatments for cancers with specific genetic changes is an important area of research. By focusing on the KRAS p.G12C mutation, scientists hope to develop more targeted medicines that work by specifically attacking the cancer cells while causing less harm to healthy cells. This kind of research is crucial for developing future cancer treatments.
Key takeaways
- This study is for adults with specific advanced cancers (KRAS p.G12C mutation).
- It's testing a new medicine called sotorasib to see if it's safe and effective.
- Participation involves taking medication and having regular medical checks.
- There are potential benefits, but also possible side effects, like any medicine.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old. Importantly, your cancer must have a specific genetic change called KRAS p.G12C. Doctors will usually detect this through special tests on your tumour tissue. Your cancer must also be considered advanced, meaning it has spread or is difficult to treat with standard methods.
There are also some reasons why you might not be able to join. For example, if your cancer has spread to your brain and is causing problems, or if you've had a heart attack in the last six months. Also, if you have severe digestive problems that would prevent you from taking medications by mouth, you wouldn't be able to participate. The study team will review all your medical information carefully 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?
- Has your doctor confirmed your cancer has the KRAS p.G12C gene change?
- Is your cancer considered advanced (spread or hard to treat)?
- Have you had a recent heart attack (within 6 months)? (If yes, you likely can't join.)
- Do you have severe digestive problems that stop you taking oral medicines? (If yes, you likely can't join.)
What does participation involve?
If you decide to take part in this study, you would primarily be taking the study medicine, sotorasib, which is likely in tablet form. You would have regular visits to the hospital or clinic for check-ups. These visits might include blood tests, scans (like CT or MRI) to see how your cancer is responding, and assessments of your general health and any side effects you might be having. Some visits might involve providing samples to see how your body processes the drug. The exact number of visits and tests will be explained by the study team, and participation will continue as long as the treatment is benefiting you and you are tolerating it well, or until the study guidelines indicate otherwise. There will also be follow-up appointments after you stop taking the study drug to monitor your health.
Potential risks and benefits
Locations (133)
- City of Hope National Medical CenterVerified postcodeDuarte, United States
- University of California Los AngelesVerified postcodeLos Angeles, United States
- University of California at SFVerified postcodeSan Francisco, United States
- Sarcoma Oncology Research Center LLCVerified postcodeSanta Monica, United States
- Rocky Mountain Cancer CentersVerified postcodeDenver, United States
- Sarah Cannon Research Institute at HealthONEVerified postcodeDenver, United States
- Smilow Cancer Hospital at Yale New HavenVerified postcodeNew Haven, United States
- Medical Oncology Hematology Consultants Helen F Graham Cancer CenterVerified postcodeNewark, United States
- University of Florida HealthVerified postcodeGainesville, United States
- AdventHealth Orlando Infusion CenterVerified postcodeOrlando, United States
- Moffitt Cancer CenterVerified postcodeTampa, United States
- Winship Cancer InstituteVerified postcodeAtlanta, United States
Common questions
What is KRAS p.G12C mutation?
It's a specific genetic change in cancer cells. Think of it like a faulty instruction that tells the cancer to grow, and this study tries to fix that fault.
What does 'advanced solid tumours' mean?
It means the cancer has either spread from where it started to other parts of the body, or it's a type of cancer that is difficult to treat with standard methods.
Is sotorasib a new medicine?
Yes, sotorasib is an investigational drug, meaning it's still being studied to see if it's safe and effective, and is not yet a standard treatment.
What will happen if I join the study?
You'll take the study medicine and have regular check-ups, blood tests, and scans to monitor your health and how the treatment is working.
Can I leave the study at any time?
Yes, you are free to withdraw from the study at any point, and your decision will not 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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