A Phase 1 Dose Finding and Phase 2 Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors
This research study is investigating new treatment options for people with advanced cancers that have spread to different parts of the body. It combines two types of treatments: GEN1042 DP and Pembrolizumab. The first part of the study aims to find the safest dose of these treatments when given together. The second part will look at how well the combination works, specifically if it can shrink tumours not directly treated. Researchers will also keep a close eye on any side effects and how long the treatments control the cancer. The goal is to find more effective and safe ways to treat these types of cancer.
At a glance
What is this study about?
This study is like a two-step investigation into new ways to treat advanced cancers that have spread in the body. Cancers that have spread are often called 'metastatic solid tumours'. The main idea behind this research is to see if combining two specific treatments, GEN1042 DP and Pembrolizumab, can be a safe and effective option.
The first part of the study, called Phase 1, is about safety. When doctors test new combinations of medicines, they need to be very careful to find the right amount, or 'dose', that can be given without causing too many serious side effects. So, in this phase, researchers will be looking closely at any unwanted effects people experience to find the safest balance.
The second part, Phase 2, builds on the safety information from Phase 1. Here, researchers will focus on how well the treatments work. They are especially interested in something called an 'abscopal response'. This means that even if only one part of the body is treated directly, other cancer sites in the body that weren't treated might also shrink. They will also look at how many people respond to the treatment, how long that response lasts, and overall how long people live while on the study. By bringing together these two treatments, the hope is to activate the body's own immune system to fight the cancer more effectively.
Key takeaways
- This study explores a new combination of treatments for advanced solid cancers.
- It aims to find a safe dose and then test how well the treatments work.
- Researchers are looking for an 'abscopal response' where untreated tumours might shrink.
- Your health would be closely monitored for any side effects.
- Participation involves regular hospital visits for treatments and checks.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Critically, you must have been diagnosed with an advanced cancer that has spread to different parts of your body, meaning it's 'metastatic'. The term 'solid tumours' means cancers that form a lump, rather than blood cancers. Your medical team will need to confirm that your specific cancer fits the study's requirements.
There will also be other specific health checks and tests to make sure that taking part in the study would be safe for you. These will be reviewed with you by the research team to ensure the study is a good fit for your individual situation.
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?
- Have you been diagnosed with cancer that has spread (metastatic)?
- Is your cancer a 'solid tumour' type?
- Are you able to visit the hospital regularly for treatments and check-ups?
What does participation involve?
Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would receive the study treatments, GEN1042 DP and Pembrolizumab, according to a schedule. Nurses and doctors would closely monitor your health, perform physical exams, take blood samples, and conduct scans to see how your body is responding to the treatment and to check for any side effects. You would also be asked about how you are feeling and any symptoms you might have. The total duration of your participation would depend on how your cancer responds to the treatment and how you tolerate it. If you decide to join, you are always free to withdraw from the study at any time.
Potential risks and benefits
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Common questions
What kind of cancer is this study for?
This study is for people with advanced cancers that have spread to other parts of the body (metastatic solid tumours).
What are 'solid tumours'?
Solid tumours are cancers that form a lump or mass, unlike blood cancers like leukaemia.
What does 'abscopal response' mean?
It means the treatment might shrink cancer in parts of your body that weren't directly treated.
Are the treatments new?
Yes, GEN1042 DP is an investigational treatment, and it's being combined with Pembrolizumab to see how they work together.
Do I have to pay to be in the study?
No, you don't pay for the study treatments or study-related medical care.
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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