A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an anti-PD-1 and anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma
This important UK study is testing a new medicine called AZD7789 for people living with a type of blood cancer called Classical Hodgkin Lymphoma. This is for patients whose cancer has either returned after treatment or hasn't responded to previous therapies. The study is divided into two main parts. The first part focuses on finding a safe dose of AZD7789 and understanding its early effects on the body. The second part will look more closely at how effective the medicine is in shrinking or getting rid of the cancer. Researchers will also be checking for any side effects and how the medicine moves through the body. The goal is to see if AZD7789 could be a helpful new treatment option for this specific type of cancer.
At a glance
What is this study about?
This study is looking into a new treatment called AZD7789 for people in the UK who have Classical Hodgkin Lymphoma. This is a type of cancer that starts in white blood cells called lymphocytes. The study is specifically for those whose cancer has either come back after previous treatments (referred to as 'relapsed') or hasn't improved with other treatments (known as 'refractory'). It's important to find new options for these patients.
The study has a few key aims. Firstly, it wants to find a safe dose of AZD7789. This involves carefully increasing the dose in different groups of people and closely monitoring them for any unwanted effects. Secondly, researchers want to understand how the medicine behaves in the body – for example, how it's absorbed, where it goes, and how quickly it's removed. Thirdly, and very importantly, they want to see if AZD7789 can help treat the cancer, such as shrinking tumours or making the cancer go away.
To achieve these goals, the study will involve different assessments. Doctors will be checking for any side effects, looking at blood tests, checking heart activity with ECGs, and monitoring vital signs like blood pressure. They will also measure how patients are feeling and their quality of life. By gathering all this information, researchers hope to determine if AZD7789 could be a promising new treatment for people with Classical Hodgkin Lymphoma.
Key takeaways
- This study is for adults with a specific type of Hodgkin Lymphoma that has returned or not responded to past treatments.
- It's testing a new medicine called AZD7789 for safety and effectiveness.
- The study involves regular hospital visits for checks and monitoring.
- Other medicines might be used to manage potential side effects.
- Your progress and general health will be closely watched throughout.
- You can choose to leave the study at any time.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. The study is open to both men and women.
While the study is generally open to adults, there will be other specific medical criteria that doctors will check to make sure the study medicine is right for you. These can include your overall health, how your heart and other organs are working, and what other treatments you've had in the past.
It's important to talk to your doctor about your complete medical history. They will be able to determine if you meet all the necessary requirements to take part in this research.
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 at least 18 years old?
- Have you been diagnosed with Classical Hodgkin Lymphoma?
- Has your Hodgkin Lymphoma either come back or not responded to previous treatments?
- Are you generally feeling well enough to participate in a study?
- Are you able to travel to study appointments?
What does participation involve?
If you decide to take part in this study, you will be given the new medicine, AZD7789. It's an 'open-label' study, which means both you and your doctor will know you are receiving the study medicine. You will visit the hospital regularly for check-ups, blood tests, heart rhythm checks (ECGs), and other assessments to monitor your health and how the medicine is working. These visits might be quite frequent at the beginning and then become less often over time.
Sometimes, other medicines like paracetamol or treatments for side effects (such as diphenhydramine, infliximab, tocilizumab, or epinephrine) might be given to help manage any reactions you might have. The study will continue for a certain period, and you will have follow-up appointments even after you stop taking the study medicine to ensure your health is fully monitored. The total duration of your participation will depend on the study's plan and your individual response.
Potential risks and benefits
Locations (4)
- —UnverifiedItaly
- —UnverifiedDenmark
- —UnverifiedSpain
- —UnverifiedFrance
Common questions
What is Classical Hodgkin Lymphoma?
It's a type of cancer that starts in the lymphatic system, which is part of your body's immune system.
What does 'relapsed or refractory' mean?
This means your cancer has either come back after treatment or didn't respond to previous treatments.
What is AZD7789?
It's a new investigational medicine being tested to see if it can help treat this type of cancer.
Will I know if I'm getting the new medicine?
Yes, this is an 'open-label' study, so you and your doctors will know you are receiving AZD7789.
What is the main goal of this study?
The main goal is to find out if AZD7789 is safe, what dose works best, and if it helps to treat your 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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