A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies
This research study is looking at a new medicine called S241656, which comes as a tablet. It's for people who have certain types of cancer where there are specific changes in their genes, such as KRAS or BRAF. These gene changes can make cancer grow. The study has two main parts. The first part aims to find the safest dose of S241656 by carefully watching for any side effects. The second part will then look at how well this medicine works against the cancer, both when given on its own and when combined with other existing cancer therapies. Researchers will also be checking for side effects throughout the study. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people.
At a glance
What is this study about?
This study is about exploring a new medicine called S241656, which is given as a tablet. It's designed for people who have certain types of cancer that are caused by specific changes in their genes. These gene changes, often called mutations, include ones like KRAS or BRAF, and can make cancer cells grow out of control. The new medicine aims to target these specific changes.
The study is split into two main sections. The first section is like a careful detective mission to find the right amount of the new medicine to give. Doctors will start with a small dose and gradually increase it for different groups of patients, watching very closely for any unwanted effects. Their main goal here is to discover the highest dose that can be given safely without causing too many problems. This helps make sure future patients get the best possible dose.
Once a safe dose is found, the second section begins. Here, the focus shifts to how well the medicine actually works against the cancer. Doctors will be checking if the tumours shrink or stop growing, and how long these effects last. They will also look at how patients feel overall. This new medicine might be given on its own, or sometimes it will be combined with other cancer treatments that patients might already be receiving. Throughout both parts of the study, everyone involved will be keeping a close eye on any side effects and how the body handles the new medicine.
Key takeaways
- Tests a new tablet medicine (S241656) for specific cancers.
- Targets cancers with certain gene changes (like KRAS, BRAF).
- Aims to find the safest dose and see how well it works.
- May involve S241656 alone or with other cancer therapies.
- Requires regular hospital visits for monitoring and tests.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old. The study is open to both men and women.
Critically, your cancer must have a specific type of gene change, also known as a mutation. These are particular changes in your cancer cells' DNA, such as a KRAS, BRAF, or other specific RAS/MAPK mutations. Your doctor would have already found this out through tests.
There might be other health requirements too, such as how well your liver and kidneys are working, or if you've recently had other cancer treatments. These details will be discussed fully with you by the study team to make sure it's safe for you to take part.
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 told you that your cancer has a specific gene change (like KRAS or BRAF)?
- Are you able to take medicines given as tablets?
- Are you able to attend regular hospital appointments for tests?
What does participation involve?
If you decide to take part in this study, you will be given the new medicine, S241656, as a tablet. Depending on which part of the study you are in, you might also receive other standard cancer treatments alongside it. You'll have regular hospital visits, where doctors and nurses will monitor your health closely. This will involve physical examinations, blood tests, and scans (like CT or MRI scans) to see how your cancer is responding and to check for any side effects.
The first part of the study focuses on finding the safest dose. This means patients in this part will start with a certain dose, and it might be adjusted based on how they respond. Later, when a safe dose is found, patients in the second part will receive this dose, either alone or with other treatments. These visits will help the study team understand how the medicine is working and how you are feeling. Throughout the study, you'll have ongoing appointments, and the total duration of your participation will depend on how you respond to the treatment and the stage of the study you are in. You’ll be told more about the schedule of visits and tests during the consent process.
Potential risks and benefits
Locations (4)
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedDenmark
- —UnverifiedItaly
Common questions
What kind of cancer is this study for?
This study is for people with certain types of cancer that have specific genetic changes (like KRAS or BRAF mutations).
What is S241656?
S241656 is a new experimental medicine, given as a tablet, that the study is testing.
Is this a new medicine?
Yes, this is an early-stage study, meaning it's one of the first times this medicine is being given to people.
Will I get other cancer treatments in this study?
Depending on the study part, you might receive S241656 alone or in combination with other standard cancer treatments.
What does 'Phase 1/2' mean?
It means the study is in its early stages. Phase 1 focuses on finding a safe dose, and Phase 2 looks at how well the medicine works.
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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