A Phase 1/2 Open-Label Multicenter Trial to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects with BRAF-V600 Mutant Solid Tumors.
This research study is looking at a new drug called CFT1946 for people with solid tumors, including melanoma, lung cancer, bowel cancer, and a type of thyroid cancer. These cancers all have a specific change in their BRAF gene. The study aims to understand if CFT1946 is safe to use and how well people tolerate it, both when given by itself and when combined with other existing medicines like Cetuximab or Trametinib. Researchers will carefully watch for any side effects and see how the body handles the new medication. They will also measure if the treatment helps to shrink tumors or stop them from growing. This is an early-stage study, meaning it's one of the first times this drug is being tested in people to find the right dose and see initial effects.
At a glance
What is this study about?
This study is about a new potential medicine called CFT1946 that could help people with certain types of cancer. These cancers, which include melanoma (a type of skin cancer), non-small cell lung cancer, colorectal (bowel) cancer, and anaplastic thyroid carcinoma, all share a common feature: they have a specific, faulty BRAF gene. This faulty gene can make cancer cells grow and spread.
Researchers want to find out if CFT1946 is a safe and effective treatment. They will test it in two ways: first, on its own (monotherapy), and then combined with other established cancer drugs called Cetuximab or Trametinib. The main goals are to understand any side effects people might experience, how well their bodies cope with the treatment, and most importantly, if the medicine can help to shrink tumors or stop the cancer from getting worse. This is an important step in developing new treatments for these specific cancers.
This is an early phase study, meaning it's among the first times this drug is being given to people. It's a crucial stage to learn about the drug's safety, find the best doses, and get an early idea of whether it works. The information gathered will help decide if CFT1946 should be studied further in larger groups of people.
Key takeaways
- This study is testing a new medicine (CFT1946) for specific cancers with a BRAF gene change.
- It aims to find out if the medicine is safe and if it can help shrink tumors.
- The study involves melanoma, lung, bowel, and thyroid cancers.
- CFT1946 will be tested alone and with other existing cancer drugs.
- It's an early-stage study to gather important information about the new treatment.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. Both men and women can take part.
There will be specific medical criteria that your doctor will check to see if this study is right for you. This often includes confirming that your cancer has the specific BRAF gene change that the researchers are targeting with the new medicine.
Your overall health and any other medical conditions you have will also be carefully reviewed to make sure it's safe for you to participate.
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 at least 18 years old?
- Has your doctor confirmed that your cancer has the specific 'BRAF-V600' gene change?
- Are you able to travel to study appointments regularly?
- Are you generally in good enough health to participate in a clinical trial?
What does participation involve?
If you join this study, you will receive the new medicine, CFT1946, either on its own or with other approved cancer treatments (Cetuximab or Trametinib). You will have regular visits to the hospital or clinic, where the study team will monitor your health very closely. These visits will likely involve blood tests, physical examinations, and scans (like CT or MRI) to see how the treatment is affecting your cancer.
They will pay close attention to any side effects you might experience and will ask you questions about how you are feeling. The exact number of visits and the total length of your participation will depend on how you respond to the treatment and the stage of the study you are in. There will also be follow-up appointments after you stop taking the study medication to continue monitoring your health.
Potential risks and benefits
Locations (4)
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- —UnverifiedItaly
- —UnverifiedGermany
Common questions
What does 'BRAF-V600 Mutant Solid Tumors' mean?
It means your cancer has a specific change in a gene called BRAF. This change can make the cancer grow, and the study medicine is designed to target it.
What is CFT1946?
CFT1946 is a new experimental medicine being tested in this study. It aims to block the faulty BRAF gene to stop cancer cells from growing.
What do 'Phase I' and 'Phase II' mean for a study?
These are early stages of testing a new drug. Phase I mainly checks safety and finds the right dose, while Phase II continues to check safety and looks for early signs that the drug works.
Will I receive the new drug or a placebo (dummy drug)?
In this particular study, all participants will receive the active study medicine, CFT1946, either alone or combined with other cancer treatments. There is no placebo.
What are 'side effects'?
Side effects are unwanted reactions or problems caused by a medicine. The study team will watch for these carefully and help manage them.
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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