A Phase 2, Safety and Efficacy Study of PRT3789 in Combination with Pembrolizumab in Patients with Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation
This research study is investigating a new treatment approach for specific types of advanced or metastatic solid tumours, including non-small cell lung cancer and oesophageal cancer. The study combines a new drug, PRT3789, with an already approved cancer medicine called Pembrolizumab (also known as KEYTRUDA). Doctors are interested in this treatment because it targets cancers that have a particular genetic change called a SMARCA4 mutation. The main goals are to see how safe the new combination is and how well it works to shrink tumours or stop them from growing. This is a Phase 2 study, meaning it's still in the earlier stages of testing in people, focusing on finding the right dose and gathering more information on its effects.
At a glance
What is this study about?
This study is about exploring a new way to treat certain advanced cancers. 'Advanced' or 'metastatic' means the cancer has spread from where it started to other parts of the body. The cancers being looked at include a type of lung cancer called non-small cell lung cancer, oesophageal cancer (cancer of the food pipe), and other solid tumours that have a specific genetic change, or 'mutation', called SMARCA4. This mutation can make cancer cells grow in a particular way.
The study combines two medicines: PRT3789, a new drug being tested, and Pembrolizumab, which is already used to treat several cancers. You might know Pembrolizumab by its brand name, KEYTRUDA. Pembrolizumab works by helping your own body's immune system fight the cancer. Researchers want to see if adding PRT3789 to Pembrolizumab makes the treatment more effective for cancers with this specific SMARCA4 genetic change.
The main aims of this study are to understand how safe this drug combination is and how well it works. Doctors will carefully monitor any side effects and see if the treatment causes tumours to shrink or stop growing. This type of study, called a Phase 2 trial, helps researchers learn more about new treatments before they can be widely available.
Key takeaways
- This study tests a new drug combination (PRT3789 + Pembrolizumab) for advanced cancers.
- It focuses on cancers with a specific genetic change called a SMARCA4 mutation.
- The goal is to check safety and how well the treatment shrinks tumours.
- It includes cancers like non-small cell lung cancer and oesophageal cancer.
- You would receive the new treatment and be closely monitored by a medical team.
Who may be eligible?
To join this study, people need to be at least 18 years old. The study is open to both men and women.
Participants must have advanced or metastatic solid tumours, which means their cancer has spread. Specifically, their cancer needs to have a particular genetic change called a SMARCA4 mutation. This might include certain types of non-small cell lung cancer or oesophageal cancer.
There might be other health requirements or previous treatments that would make someone suitable or unsuitable for this study. These details would be discussed fully by the study doctor.
- Are you 18 years or older?
- Do you have advanced or metastatic cancer?
- Does your cancer have a SMARCA4 genetic mutation?
- Has your doctor discussed this study with you?
- Are you open to trying a new treatment combination?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the study drugs, PRT3789 and Pembrolizumab, according to a schedule set by the researchers. This will involve regular visits to the clinic for treatments and check-ups. During these visits, the study team will carry out various tests and assessments to monitor your health and how the treatment is working. This will likely include blood tests, scans (like CT scans) to check your tumour, and discussions about any side effects you might be experiencing.
They will record information about how the medicines are affecting your body, including any side effects, changes in lab results, and whether your cancer is responding. The total length of your participation would depend on how your body responds to the treatment and the study's design. You would be kept informed about what to expect at each stage.
Potential risks and benefits
Locations (3)
- —Spain
- —Germany
- —France
Common questions
What does 'SMARCA4 mutation' mean?
It's a specific genetic change in your cancer cells that researchers believe makes the cancer respond to certain treatments in a particular way.
What is Pembrolizumab (KEYTRUDA)?
It's an existing cancer medicine that helps your body's immune system recognise and fight cancer cells.
What is a Phase 2 study?
It's an early stage of testing a new treatment in a small group of people to see if it's safe and how well it works.
Will I definitely get the new drug?
Yes, in this study, all participants receive the combination of the new drug PRT3789 and Pembrolizumab.
What are 'solid tumours'?
These are cancers that form solid lumps or masses, unlike blood cancers. Examples include lung, breast, or bowel cancer.
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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