A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD9793, a T cell-engaging Antibody Targeting Glypican-3 (GPC3) in Adult Participants with Advanced or Metastatic Solid Tumours (RHEA-1)
This research study, called RHEA-1, is looking into a new treatment called AZD9793 for adults who have advanced solid tumours, which are cancers that have spread or are difficult to treat. The study is particularly focused on liver cancer (hepatocellular carcinoma). AZD9793 is a type of medicine designed to help your body's own immune system fight cancer. Since this is an early-stage study (Phase I/II), researchers are carefully checking its safety and how much medicine is best to give. They also want to see if the medicine helps shrink tumours and how it works in the body. The aim is to find out if AZD9793 could be a helpful new option for people with these types of cancer.
At a glance
What is this study about?
This study, known as RHEA-1, is exploring a new medicine called AZD9793. It's designed for adult patients who have advanced solid tumours, which means their cancer has grown or spread in a way that makes it harder to treat. The main focus of this study is on a specific type of liver cancer called hepatocellular carcinoma.
AZD9793 is a special type of medicine that works with your body's immune system, which is its natural defence against illness. It's designed to help your immune cells, specifically T cells, find and attack cancer cells. This type of treatment is often called 'T cell-engaging' because it helps engage your own T cells in fighting the cancer.
Because this is an early-stage study (Phase I and II), the research team is first and foremost checking the safety of AZD9793. They will carefully increase the dose to find the right amount that is both safe and effective. They will also look at how the medicine moves through your body and if it can help shrink tumours. The goal is to see if AZD9793 can be a new and effective treatment option for patients with these challenging cancers.
Key takeaways
- It's a study for a new medicine (AZD9793) for adult patients with advanced solid tumours, particularly liver cancer.
- The medicine aims to boost your immune system to fight cancer.
- This is an early-stage study focusing on safety and finding the best dose.
- Participation involves regular visits for treatment and health checks.
- Potential benefits include access to a new treatment, but risks of side effects exist.
Who may be eligible?
This study is open to adult patients aged 18 and over, with no upper age limit. Both men and women are welcome to take part.
To be considered for the study, you must have advanced solid tumours, with a particular focus on hepatocellular carcinoma (a type of liver cancer). This means your cancer has either spread to other parts of your body or is difficult to treat with standard methods.
The research team will carry out several tests to make sure that taking part in the study is safe and appropriate for you. They will check your medical history and current health to ensure you meet all the specific requirements of 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 an adult aged 18 or older?
- Do you have advanced solid tumours?
- Has your doctor confirmed you have hepatocellular carcinoma (a type of liver cancer)?
- Are you able to attend regular hospital appointments for treatment and check-ups?
- Are you willing to follow the study's specific treatment plan and tests?
What does participation involve?
Taking part in this study would involve regular hospital visits for check-ups and to receive the study medication, AZD9793. During these visits, the research team will monitor your health very closely. You will have blood tests and other assessments to check how the medicine is affecting your body and the cancer.
These assessments include checking for any side effects and seeing how the medicine is cleared from your body. They will also measure the size of your tumours over time to see if the treatment is working. The study begins with carefully increasing the dose of the medicine for some participants, then continues with a larger group receiving what is found to be a suitable dose.
The total duration of your participation will depend on how you respond to the treatment and the study plan, but there will be regular follow-up visits even after you stop receiving the study medication to ensure your well-being. The team will explain the full schedule of visits and tests to you in detail.
Potential risks and benefits
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Common questions
What kind of cancer is this study for?
This study is for adults with advanced solid tumours, especially a type of liver cancer called hepatocellular carcinoma.
What is AZD9793?
AZD9793 is a new medicine being tested. It's designed to help your body's immune system fight cancer cells.
Will this medicine cure my cancer?
This is an early-stage study, mainly focused on safety and finding the right dose. While it aims to help, it's too soon to know if it can cure cancer.
What does 'Phase I/II' mean?
It means this is primarily one of the first times this medicine is being given to people. Researchers are carefully checking its safety and effectiveness before larger studies.
Will I have to pay to be in the study?
No, you will not have to pay for the study medication or related medical care you receive as part of the trial.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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