A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Clinical Activity of RO7276389 Alone and in Combination with Cobimetinib in Participants with BRAF-V600 Mutation-Positive Advanced Solid Tumor or BRAF-V600 Mutation-Positive Melanoma with Central Nervous System Metastases
This research study is testing a new medication called RO7276389. It's being studied on its own and in combination with another approved cancer drug, cobimetinib. The main goal is to understand if RO7276389 is safe for people to take, how it moves through the body, and if it shows any early signs of helping against certain cancers. This particular study focuses on adults whose cancers have a specific genetic change called a BRAF-V600 mutation. This includes advanced solid tumours (cancers that form a lump) or melanoma (a type of skin cancer) that has spread, even to the brain or spine (central nervous system). This is an early stage of human testing, meaning it's one of the first times people are given this new drug.
At a glance
What is this study about?
This study is about a new cancer treatment called RO7276389. We know that some cancers have specific changes in their genetic code, like the BRAF-V600 mutation. These changes can make cancer grow and spread. This new drug is designed to target cells with this specific mutation.
The researchers want to see how this new drug works, both by itself and when given with an existing cancer medicine called cobimetinib. They'll be watching closely to see if it's safe for people to take and how the body handles it. They will also look for any early signs that the treatment is helping to slow down or shrink the cancer.
This is a 'Phase I' study, which means it's one of the first times this new drug is being tested in people. These early studies are really important for understanding new medicines before they can be tested on larger groups of patients. The information gathered here will help doctors decide if this treatment has the potential to help people with advanced cancers that have this specific BRAF-V600 mutation, including melanoma that has spread to the brain.
Key takeaways
- This study is for adults with specific advanced cancers.
- It's testing a new drug, RO7276389, alone and with another called cobimetinib.
- The cancer must have a genetic change called a BRAF-V600 mutation.
- This includes melanoma that has spread to the brain.
- It's an early-stage study to check drug safety and how it works.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.
The main condition for joining is that you must have an advanced solid tumour (a cancer that forms a lump) or melanoma (a type of skin cancer) that your doctor has confirmed has a specific genetic change called a BRAF-V600 mutation. This includes cases where the melanoma has spread to the brain or spinal cord.
There might be other specific health requirements or conditions that would mean you can't join the study, even if you meet these main points. Your doctor or the study team will go through all of these in detail with you to make sure the study is a good fit and safe 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 you have an advanced solid tumour or melanoma?
- Has your cancer been tested and found to have a BRAF-V600 mutation?
- Are you able to attend regular clinic visits for treatment and tests?
What does participation involve?
If you decide to take part in this study, you would receive the study medication (RO7276389, either alone or with cobimetinib) according to a set schedule. This would involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These tests help the doctors understand if the treatment is safe and if it's working.
The visits might be more frequent at the beginning of the study. You would also have regular discussions with the study team to report any side effects or changes to your health. The total time you would be involved in the study can vary, but it includes the period you receive the treatment and a follow-up period afterwards to continue monitoring your health.
Potential risks and benefits
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Common questions
What is a BRAF-V600 mutation?
It's a specific change in the DNA of some cancer cells that can make them grow faster. Doctors can test for this.
Why combine two drugs?
Sometimes, using two different drugs together can be more effective at fighting cancer than using just one.
What does 'advanced solid tumour' mean?
It means a cancer that forms a lump and has spread from where it first started, or has come back after treatment.
What is a 'Phase I' study?
It's an early stage of testing a new drug in a small group of people to see if it's safe and how it behaves in the body.
Will this drug cure my cancer?
It's too early to say. This study aims to understand if the drug is safe and shows any early signs of helping, not to prove a cure.
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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