APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
This research study is looking at a new medicine called APL-101, taken as a capsule, for adult patients with advanced solid cancers. It specifically targets cancers, including non-small cell lung cancer (NSCLC), that have certain genetic changes involving a protein called MET. These changes might include a 'MET Exon 14 skip mutation' or 'MET amplification'. The study aims to understand how effective APL-101 is at treating these cancers, both on its own and in combination with other treatments for specific lung cancers. It will also carefully check for any side effects to make sure the medicine is safe and well-tolerated. This is a Phase 2 study, meaning the earlier safety checks have been done, and now the focus is on how well it works.
At a glance
What is this study about?
This study is investigating a new oral medication called APL-101 for people living with advanced cancers. Advanced cancer means the cancer has spread from where it started. Doctors are particularly interested in how APL-101 works in specific types of cancer, like a kind of lung cancer called non-small cell lung cancer (NSCLC), and other solid tumours. The key focus is on cancers that have particular changes in their genes related to a protein called 'MET'. These changes, such as a 'MET Exon 14 skip mutation' or 'MET amplification', can make the cancer grow and spread. Another type of change is a 'MET fusion'. The study also looks at cancers where there are ‘MET alterations’ in brain tumours, and situations where MET protein is found in high amounts alongside another protein called HGF.
The main aim of this study is to see how well APL-101 can shrink or stop the growth of these cancers. Researchers are testing it in different ways: as the only treatment (monotherapy) for cancers with these specific MET changes, and also combined with another medicine for certain lung cancers. For example, some lung cancers with an EGFR gene change might stop responding to their usual treatment; if they also develop MET amplification, APL-101 might help in addition to their current medicine. This is a Phase 2 study, which means that early safety tests have already been successfully completed, and now the focus is on how effective the medicine is and carefully monitoring for any side effects in a larger group of patients.
Key takeaways
- This study is for adults with advanced solid cancers, including specific lung cancers.
- It focuses on cancers with certain 'MET' genetic changes.
- The new medicine, APL-101, is taken as an oral capsule.
- It aims to see if APL-101 can shrink or stop cancer growth, and if it's safe.
- Some patients might receive APL-101 alongside another lung cancer drug.
- Regular check-ups and scans will monitor your health and cancer's response.
Who may be eligible?
To join this study, you must be 18 years or older. The study is looking for patients with advanced solid tumours, which means the cancer has spread. A very important part of joining is that your cancer must have specific genetic changes involving the 'MET' protein, such as 'MET Exon 14 skip mutation', 'MET amplification', or 'MET fusion'. Your doctors will do tests to see if your cancer has these particular changes.
Depending on your specific cancer type and whether you've had treatment before, you might fit into different groups within the study. For example, some groups are for people with non-small cell lung cancer who have not had treatment for this specific MET change before, while others are for those who have had some previous treatments (up to three lines of therapy). There are also groups for various other solid tumours with MET changes. The study also includes a specific group of lung cancer patients whose cancer has stopped responding to an EGFR inhibitor and has developed MET amplification.
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 advanced solid cancer (not blood cancer)?
- Have your doctors found specific 'MET' genetic changes in your cancer?
- Are you able to take medicines by mouth?
- Are you willing to have regular medical checks and scans?
What does participation involve?
If you join this study, you will be taking APL-101 as oral capsules. The exact number of visits and the duration of your participation will depend on how you respond to the treatment and which group you are in. You will have regular appointments with the study team for check-ups, which will include physical exams, blood tests, and scans (like CT or MRI scans) to see how your cancer is responding to the medicine. These tests also help the doctors monitor your health and check for any side effects. You'll continue taking the study medicine as long as it's helping you and you are not experiencing significant side effects. The study team will explain all the details, including how often you'll need to come in and what tests you'll have, before you decide to take part.
Potential risks and benefits
Locations (35)
- Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer InstituteVerified postcodeLos Angeles, United States· Recruiting
- MoffittVerified postcodeTampa, United States· Active not recruiting
- Dana Farber Cancer InstituteVerified postcodeBoston, United States· Active not recruiting
- University of North CarolinaVerified postcodeChapel Hill, United States· Recruiting
- Penn State Milton S. Hershey Medical CenterVerified postcodeHershey, United States· Recruiting
- University of WisconsinVerified postcodeMadison, United States· Recruiting
- St Vincents Hospital MelbourneVerified postcodeMelbourne, Australia· Recruiting
- Cross Cancer InstituteVerified postcodeEdmonton, Canada· Recruiting
- McGill University Health Center - Research InstituteVerified postcodeMontreal, Canada· Recruiting
- Princess Margaret HospitalVerified postcodeToronto, Canada· Recruiting
- Cancer Care ManitobaVerified postcodeWinnipeg, Canada· Recruiting
- CHRU de Brest - Hôpital MorvanVerified postcodeBrest, France· Recruiting
Common questions
What is a 'MET Exon 14 skip mutation'?
It's a specific genetic change in cancer cells that affects the MET protein, which can cause the cancer to grow.
What does 'advanced solid tumours' mean?
This means your cancer has spread from where it started to other parts of your body, and it's not a blood cancer.
Is APL-101 a chemotherapy drug?
No, APL-101 is a 'targeted therapy', meaning it's designed to specifically block the MET protein changes seen in certain cancers, rather than a general chemotherapy.
How long will I be in the study?
You will stay in the study as long as the medicine is helping you and you are tolerating it well. The study team can give you a more specific estimate.
Can I continue my other medications?
You must tell the study team about all medications you are taking. They will tell you if any need to be stopped or changed during the study.
How to find out more
Emma (Xiaoning) Cai
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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