An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumour Activity of WEF-001 in participants with Advanced KRAS- Mutant Solid Tumours.
This study is investigating a new medication, WEF-001, for people diagnosed with advanced solid tumours that have a specific genetic change known as a KRAS mutation. This is an early-stage study, meaning it’s one of the first times this medicine is being tested in humans. The main goals are to find out how safe the medicine is, what side effects it might cause, and how the body handles it. Researchers will also be looking to see if WEF-001 can help to stop the cancer from growing or even shrink the tumours. This information will help doctors understand if WEF-001 could be a helpful treatment option in the future.
At a glance
What is this study about?
This study is designed to explore a new potential cancer treatment called WEF-001. We're inviting people who have advanced solid tumours with a specific genetic change, known as a KRAS mutation. Understanding this mutation is important because it can sometimes make cancers harder to treat with standard therapies. This research is in its early stages, often called Phase 1 and Phase 2a, which means it’s among the first times this new medicine is being tested in people.
The main aims of the study are to carefully check the safety of WEF-001. This involves watching for any side effects and seeing how people tolerate the medicine. We also want to understand how the body processes the medicine, for example, how much of it reaches the tumour and how long it stays in the body. Crucially, the study will also look at whether WEF-001 has an anti-tumour effect, meaning if it can stop the cancer from growing or even make tumours smaller.
By gathering all this information, doctors and researchers hope to learn if WEF-001 could become a valuable new treatment for people with these specific types of advanced cancers. It’s an important step in developing new ways to fight cancer and improve patient outcomes.
Key takeaways
- This study is testing a new medicine called WEF-001 for advanced solid tumours with a specific KRAS gene change.
- The main goals are to check the medicine's safety, how it affects the body, and if it can shrink tumours.
- It's an early-stage study, meaning WEF-001 is still being investigated and is not yet available as a standard treatment.
- Participants will receive the study medicine and have frequent medical check-ups and tests.
- Potential benefits include access to a new treatment, but there are also unknown risks and side effects.
- You can stop participating in the study at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. You must have advanced solid tumours that have a specific genetic change called a KRAS mutation.
Your doctors will check your overall health and medical history to make sure that taking part in the study would be safe for you. This will involve reviewing your past and current medical conditions and making sure you meet specific health requirements for the study.
There might be other specific criteria that your doctor will discuss with you. These could include details about your cancer’s stage, previous treatments you’ve had, and certain blood test results. It's important to discuss everything with your doctor 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?
- Have you been diagnosed with an advanced solid tumour?
- Does your tumour have a specific KRAS gene mutation?
- Are you generally well enough to participate in a clinical study?
What does participation involve?
If you decide to take part in this study, you will receive the new medicine, WEF-001. This study involves regular visits to the hospital or clinic so the study team can monitor your health very closely. During these visits, you can expect to have blood tests, physical examinations, and scans to see how your body is reacting to the treatment and whether the cancer is responding.
The study also involves careful monitoring for any side effects you might experience. The total duration of your participation in the study will depend on how you respond to the treatment and will be thoroughly explained by the study team. They will also discuss specific details about the frequency of visits and assessments.
Potential risks and benefits
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Common questions
What is a 'solid tumour'?
A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Most cancers are solid tumours.
What does 'KRAS mutation' mean?
A KRAS mutation is a specific change in a gene within your cancer cells. This change can sometimes affect how the cancer grows and responds to treatments.
What is 'Phase 1/2a'?
This means it's an early-stage study. Phase 1 focuses on safety and finding the right dose, while Phase 2a starts to look at how well the medicine works.
Will I know if the medicine is helping my cancer?
The study team will regularly perform scans and tests to monitor your cancer. They will share updates with you on how the treatment is affecting your tumour.
Is WEF-001 already approved as a medicine?
No, WEF-001 is an investigational medicine, meaning it is still being studied and is not yet approved for general use. It’s a potential new treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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