A Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0022 Monotherapy and in Combination with Anti-cancer Agents in Participants with Tumours Harbouring a KRASG12D Mutation (ALAFOSS-01)
This research study is testing a new medicine called AZD0022. It's for people who have certain types of lung cancer (non-small cell lung cancer), bowel cancer (colorectal cancer), or pancreatic cancer. Specifically, it's for those whose cancer has a particular gene change called KRASG12D. The main goals are to find out if AZD0022 is safe to use, what side effects it might cause, and how much of it stays in the body. Doctors also want to see if this new drug, either by itself or when given with other cancer treatments like Erbitux, can help shrink tumours. This is one of the first times this drug is being given to people.
At a glance
What is this study about?
This study is about a new potential medicine called AZD0022, which doctors are hoping could help treat certain types of cancer. These include non-small cell lung cancer, colorectal (bowel) cancer, and pancreatic cancer. What's special about this study is that it's focusing on cancers that have a specific genetic change, or 'mutation,' known as KRASG12D. This mutation can make cancer cells grow in a particular way, and AZD0022 is designed to target this specific change.
This research is happening in two main parts, called Phase I and Phase II. In Phase I, the doctors are primarily concerned with safety. They will give AZD0022 to people for the first time to understand what doses are safe, what side effects might occur, and how the body processes the medication. In Phase II, if the drug is shown to be safe, they will look more closely at whether it can actually help shrink tumours or slow down cancer growth.
The study will test AZD0022 on its own and also in combination with other anti-cancer medicines, such as Erbitux. By doing this, researchers hope to discover if AZD0022 could become a new treatment option for people living with these challenging cancers.
Key takeaways
- Tests a new drug (AZD0022) for specific lung, bowel, and pancreatic cancers.
- Aimed at cancers with a KRASG12D gene mutation.
- Checks for safety and how well the body handles the drug.
- Also explores if it can shrink tumours, alone or with other treatments.
- One of the first studies involving this drug in people.
- Participation involves regular hospital visits for monitoring.
Who may be eligible?
To join this study, participants must be at least 18 years old. Both men and women can take part. A very important requirement is that your cancer must have a specific change in its genes, called a KRASG12D mutation. This mutation will be checked by your doctors.
Beyond these basic requirements, the research team will need to review your full medical history. They will check things like your general health, how well your organs are working, and any other medical conditions you might have. This is to make sure that taking part in the study would be safe for you.
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.
- Am I at least 18 years old?
- Do I have non-small cell lung cancer, colorectal cancer, or pancreatic cancer?
- Has my doctor confirmed my cancer has a KRASG12D gene mutation?
- Am I generally well enough to participate in a clinical study?
- Am I able to attend regular hospital appointments?
What does participation involve?
If you decide to join this study, you would first undergo a series of medical tests to confirm you meet all the requirements. Once you're in, you'll receive the study drug, AZD0022, which might be given alone or with another cancer drug, Erbitux, depending on which part of the study you are in. The study involves regular visits to the hospital or clinic for blood tests, physical examinations, and scans (like CT or MRI scans) to see how your body is responding to the treatment and if your tumour size changes.
You'll be closely monitored for any side effects, and your health will be checked with measurements like blood pressure, heart rate, and heart electrical activity (ECG). The total length of your participation would depend on how your body responds to the treatment and whether you experience any difficult side effects. After stopping the study drug, there will be follow-up visits to ensure your continued well-being.
Potential risks and benefits
Locations (5)
- —UnverifiedBelgium
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedSpain
Common questions
What is AZD0022?
It's a new medicine being tested to see if it can treat certain types of cancer with a specific gene change.
What kind of cancers is this study for?
It's for people with non-small cell lung cancer, colorectal (bowel) cancer, and pancreatic cancer, specifically if their cancer has a KRASG12D gene mutation.
What does 'Phase I/IIa' mean?
It means this is one of the first times people are taking the drug (Phase I to check safety) and also looking at whether it helps shrink tumours (Phase IIa).
Will I take AZD0022 alone or with other drugs?
It might be given on its own or with another cancer drug called Erbitux, depending on which part of the study you're in.
Can anyone join this study?
You must be at least 18 years old, and your cancer must have a specific genetic change called KRASG12D. Doctors will check other health details too.
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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