Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours
This study is a research project looking into a new medicine called DO-2. It's designed for people with advanced solid tumours, which are cancers that have spread or are difficult to treat. This includes specific types of lung cancer (non-small cell lung cancer) and other solid tumours that have particular genetic changes called 'MET aberrations', and for which standard treatments are no longer effective or available. The main goals are to find out if DO-2 is safe for people to take, what side effects it might have, and how it's handled by the body. This is an early-stage study, meaning it's one of the first times this medicine is being tested in humans.
At a glance
What is this study about?
This study is a clinical trial, which means it's a carefully planned research project to test a new medicine, in this case called DO-2. This medicine is for adults who have different kinds of advanced solid tumours. 'Advanced' means the cancer has spread or is difficult to treat with current standard options. The study is particularly looking at people whose tumours have a specific genetic change, or 'MET aberration', especially those with a type of lung cancer called non-small cell lung cancer (NSCLC) where standard treatments are no longer working or available.
The main purpose of this study is to learn more about DO-2. Because it's a new medicine, the researchers first need to understand if it's safe to use and what the right dose might be (this was done in 'Part 1' of the study). Now, in 'Part 2', they are giving DO-2 to more people with lung cancer to see how well it works and to continue checking its safety and how the body processes it. This type of study is crucial for learning about new potential cancer treatments.
It's important to remember that this is an early-stage study (Phase 1). This means the main focus is on safety and understanding the medicine, rather than definitively proving it's effective as a treatment. However, the hope is that medicines like DO-2 could offer new options for people with certain types of cancer that are currently very challenging to treat.
Key takeaways
- This study is testing a new, experimental drug called DO-2 for advanced solid tumours.
- It's for people whose cancers have a specific genetic change (MET aberration or MET exon 14 skipping mutation).
- The main goals are to check the drug's safety and how the body handles it.
- Participation involves taking the drug by mouth and regular clinic visits for checks.
- It's an early-stage study, so the long-term effects and benefits are still being learned.
Who may be eligible?
This study is for adults generally aged 18 or older. To be considered, you must have a type of advanced solid tumour that is difficult to remove with surgery or has spread to other parts of the body. Particularly, if you have non-small cell lung cancer (NSCLC), standard treatments should no longer be working for you.
A very important requirement is that your tumour must have a specific genetic change called a 'MET exon 14 skipping mutation'. This needs to be confirmed by a recent genetic test. You should also be generally well enough to take part in the study, meaning you can mostly look after yourself and have healthy blood, liver, and kidney function.
There are also some reasons why you wouldn't be able to join. For example, if your cancer has other specific genetic changes that promote growth, or if you've recently had major surgery, chemotherapy, or certain other cancer treatments within the last few weeks. People with uncontrolled heart problems or active brain tumours (unless they are stable and not bothering you) would also not be able to participate. You must also agree to use contraception if necessary during the study.
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 an advanced solid tumour, especially non-small cell lung cancer, where standard treatments are no longer working?
- Has a recent test shown your tumour has a 'MET exon 14 skipping mutation'?
- Are you generally well and active, and your organs (like liver and kidneys) are functioning well?
- Have you avoided major surgery, chemotherapy, or certain other cancer treatments in the last few weeks?
What does participation involve?
If you join this study, you will be taking the study medicine, DO-2, as a tablet by mouth. The study is designed in two main parts, and while the first part (finding the right dose) is complete, the second part focusing on more patients with non-small cell lung cancer is ongoing. You will have regular visits to the clinic for medical checks, blood tests, and scans to see how you are responding to the medicine and to monitor any side effects.
The specific number of visits and tests will be detailed by the study team, but generally, you can expect frequent check-ups, especially at the beginning, and then potentially less often if you continue on the treatment. The total duration of your participation will depend on how you respond to the medicine and your overall health, but it could last for several months or longer. You will be closely monitored throughout.
Potential risks and benefits
Locations (13)
- Institut Roi Albert II - UC LouvainVerified postcodeBrussels, Belgium· Recruiting
- UZAVerified postcodeEdegem, Belgium· Recruiting
- Universitair Ziekenhuis GentVerified postcodeGhent, Belgium· Recruiting
- UZ LeuvenVerified postcodeLeuven, Belgium· Recruiting
- Institut BergonieVerified postcodeBordeaux, France· Recruiting
- Institut Cœur Poumon - CHU LilleVerified postcodeLille, France· Recruiting
- Centre Léon BérardVerified postcodeLyon, France· Recruiting
- Hôpitaux Universitaires de Marseille TimoneVerified postcodeMarseille, France· Not yet recruiting
- Centre Antoine LacassagneVerified postcodeNice, France· Not yet recruiting
- Centre Hospitalier Universitaire De RennesVerified postcodeRennes, France· Recruiting
- Institut Gustave RoussyVerified postcodeVillejuif, France· Not yet recruiting
- Radboud UMCVerified postcodeNijmegen, Netherlands· Recruiting
Common questions
What is a 'solid tumour'?
A solid tumour is a type of cancer that forms a solid mass of tissue, unlike blood cancers like leukaemia.
What does 'advanced or refractory' mean?
'Advanced' means the cancer has spread or is extensive. 'Refractory' means the cancer hasn't responded well to previous treatments.
What is a 'MET aberration' or 'MET exon 14 skipping mutation'?
These are specific genetic changes found in some cancer cells that can make the cancer grow. The study medicine targets cells with this change.
What phase is this study in?
This is a Phase 1 study, which is an early stage of clinical research primarily focused on checking the safety of a new medicine and finding the right dose.
Will this medicine cure my cancer?
It's too early to say if DO-2 will cure cancer. Early-stage studies like this focus on safety and understanding the medicine, hoping it might offer a new way to control the disease.
How to find out more
Timothy Perera, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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