A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and expansion study of the oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP inhibitor (PARPi) niraparib in adult participants with solid tumors.
This research study is investigating a new oral medicine called GSK4524101, which works by targeting a specific protein in cancer cells, in combination with an existing cancer drug called niraparib, also known as Zejula. The study is for adults who have solid tumours, which are solid masses of cancer cells. It's being carried out in two main parts. The first part focuses on finding a safe dose for the new combination by carefully checking for any side effects. The second part will then look at how well this combined treatment might shrink tumours and help control the cancer, while continuing to monitor for safety. The goal is to see if this new approach could be a helpful treatment option.
At a glance
What is this study about?
This study is a clinical trial exploring a new potential treatment for adults with solid tumours (cancers that form a lump, rather than being in the blood, for example). It's a 'Phase 1/2' study, which means it has two main parts. Phase 1 is about ensuring the treatment is safe and finding the right dose, while Phase 2 looks at how well the treatment works and continues to check for safety.
The treatment being tested combines two different types of drugs. One is a new medicine called GSK4524101, which works by stopping cancer cells from repairing their DNA, making it harder for them to grow and spread. The other drug is niraparib, which you might know by its brand name, Zejula. Niraparib is another cancer drug that also interferes with DNA repair in cancer cells. The idea is that using these two drugs together might be more effective at fighting cancer.
Researchers will be carefully watching study participants for any side effects and will adjust the dose of the new drug as needed to find a balance between effectiveness and safety. They will also measure how much of the drugs are in the body and how long they stay there. Eventually, they will assess if the combination treatment can shrink tumours and slow down the cancer's growth. This type of research is crucial for developing new and better ways to treat cancer.
Key takeaways
- This study tests a new treatment for adults with solid tumours.
- It combines a new drug with an existing cancer medicine, niraparib (Zejula).
- The first part aims to find a safe dose; the second part checks how well it works.
- Regular hospital visits, medication, and monitoring are involved.
- There's a potential for new treatment, but also risks of side effects.
- You can withdraw from the study at any time without affecting your normal care.
Who may be eligible?
This study is open to adults aged 18 years and older. Both men and women can take part.
To be eligible, you will need to have a type of cancer known as a 'solid tumour'. This means your cancer forms a solid mass, rather than being a blood cancer. There will also be other specific medical criteria that your doctor will need to check to make sure the study is a good fit for you.
Factors like your overall health, any other medical conditions you have, and previous treatments you've received will be carefully reviewed by the study team. This is to ensure your safety and that the study results are clear and reliable.
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 type of cancer called a 'solid tumour'?
- Are you able to take medicines by mouth?
- Are you otherwise well enough to take part in a clinical trial, as assessed by your doctor?
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would have medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. You would be taking the study medications (GSK4524101 and niraparib/Zejula) orally, likely as tablets.
The study starts with a 'dose escalation' phase, meaning the dose of the new drug will be gradually increased in different groups of participants until a safe and effective dose is found. You would be closely monitored during this period, especially for any side effects. The total duration of your participation would depend on how your body responds to the treatment and the phase of the study you are in, but it generally involves ongoing treatment and follow-up.
Potential risks and benefits
Locations (8)
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- —UnverifiedItaly
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- —UnverifiedBelgium
- —UnverifiedGreece
Common questions
What are 'solid tumours'?
Solid tumours are cancers that form a lump or a mass, unlike blood cancers like leukaemia.
What does a 'Phase 1/2' study mean?
Phase 1 is about finding a safe dose and checking for side effects, while Phase 2 then looks at how well the treatment works against the cancer, still paying close attention to safety.
Will I know if I'm getting the new drug?
This is an 'open-label' study, which means both you and your study doctor will know which medication you are receiving.
What are the drugs being tested?
The study is testing a new drug called GSK4524101 in combination with an existing cancer drug known as niraparib (Zejula).
What if I experience side effects?
The study team will monitor you very closely for any side effects and will provide support and medical care as needed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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