Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
This research study is looking at a new medicine called WEF-001 for people with advanced solid cancers that have a particular genetic fault known as a 'KRAS mutation'. These types of cancers include pancreatic, bowel, and lung cancer, among others. The main aims are to check if WEF-001 is safe to use and how well people tolerate it. Researchers will also be looking at how the medicine works in the body and if it shows any signs of shrinking tumours. This is an early-stage study, meaning it’s one of the first times this medicine is being tested in humans. It will help us understand if WEF-001 could be a useful new treatment in the future.
At a glance
What is this study about?
This study is about a new medicine called WEF-001. Doctors are trying to find new and better ways to treat certain advanced cancers. These specific cancers have a particular genetic change, or 'mutation', in a gene called KRAS. This means the cancer cells have a faulty KRAS gene that helps them grow. Researchers hope that WEF-001 might be able to target and stop these faulty KRAS genes from working, which could slow down or shrink the cancer.
This is an early-stage study (called Phase 1/2a). This first part of the study focuses on safety. The medical team will carefully watch participants to see if the medicine causes any side effects and how strong a dose can be given safely. They will also look at how much of the medicine gets into the body and how long it stays there.
Once the safety is understood, they will start looking for early signs that the medicine might be working to help the cancer. This is called 'preliminary efficacy' – meaning they want to see if there are any hints that the tumours are getting smaller or stopping growing. This study is important because KRAS-mutant cancers can be challenging to treat, and new options are always needed for patients.
Key takeaways
- This study is for advanced cancers with a specific 'KRAS mutation'.
- It's testing a new medicine called WEF-001 for safety and early signs of effectiveness.
- Potential cancers include certain advanced pancreatic, bowel, and lung cancers.
- Participants must have tried at least one standard treatment already.
- Regular hospital visits and health monitoring will be part of the study.
Who may be eligible?
To join this study, you would need to be an adult (18 or older) and have an advanced solid cancer that has a 'KRAS mutation'. This includes certain types of pancreatic, bowel (colorectal), lung, ovarian, bile duct (cholangiocarcinoma), or bladder cancer. Your cancer would also need to have grown or spread even after trying at least one standard treatment.
Doctors will also check your general health. For example, your liver should be working well, and you shouldn't have certain ongoing infections, serious heart problems, or untreated brain tumours. You also shouldn't have other active cancers that need treatment or conditions like active inflammatory bowel disease or recent lupus. The medical team will review your full health history to make sure the study is a safe option 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?
- Do you have a doctor who has confirmed your cancer has a 'KRAS mutation'?
- Has your cancer grown or spread after trying at least one standard treatment?
- Do you feel well enough to participate in a study, generally speaking?
- Do you have advanced pancreatic, bowel, lung, ovarian, bile duct, or bladder cancer?
What does participation involve?
If you decide to take part, you would be given the new medicine, WEF-001, on its own. You would have regular visits to the clinic for check-ups, blood tests, and scans (like X-rays or CT scans) to see how you're responding to the treatment and to monitor for any side effects. The medical team will explain the full schedule of visits and tests during the screening process. You would continue treatment for as long as it is helping you and you are tolerating it well. Total duration in the study varies per patient, depending on how you respond to the treatment.
Potential risks and benefits
Locations (4)
- NEXT Oncology DallasVerified postcodeDallas, United States· Recruiting
- Next Oncology, San AntonioVerified postcodeSan Antonio, United States· Recruiting
- Princess Margareth Cancer CenterVerified postcodeToronto, Canada· Recruiting
- Oxford University HospitalVerified postcodeHeadington, United Kingdom· Recruiting
Common questions
What does 'KRAS mutation' mean?
It's a specific genetic change in your cancer cells that helps them grow. This study is looking at a medicine designed to target this change.
Is WEF-001 a pill or an injection?
The study description only mentions WEF-001, not how it's given. The study team would explain this if you consider participating.
Will I get standard cancer treatment too?
In this study, WEF-001 is given on its own (as 'monotherapy'), so you wouldn't be receiving other cancer treatments at the same time.
What kind of monitoring will I have?
You'll have regular medical check-ups, blood tests, and scans to see how you're doing and if the medicine is affecting your body or cancer.
How long will I be in the study?
You'll stay in the study as long as the treatment is helping you and you're tolerating it well. This duration can be different for each person.
How to find out more
Michele Finn, MSc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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