A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination with a Checkpoint Inhibitor with or without Standard-of-Care Chemotherapy in Patients with Locally Advanced or Metastatic Solid Tumors
This study is for people with advanced solid tumours that have spread or can't be removed with surgery. It aims to understand if a new medicine called RO7496353 is safe to use and how it acts in the body. Researchers want to see how this new medicine works when given by itself, and also when combined with other existing cancer treatments. These existing treatments can include an 'immunotherapy' drug (which helps your body's immune system fight cancer) and/or standard chemotherapy. This is a very early-stage study, meaning it's one of the first times this new medicine is being used in people.
At a glance
What is this study about?
This study is looking into a new treatment called RO7496353 for people who have solid tumours that are advanced. This means the cancer may have spread to other parts of the body (metastatic) or is too advanced to be treated with surgery or local treatments. We want to understand how safe this new medicine is and how it behaves once it’s in your body. We will also be looking at how well it works, both on its own and when combined with other established cancer treatments.
Some people in the study will receive RO7496353 alongside a type of treatment called a 'checkpoint inhibitor'. This is a form of immunotherapy that helps your body's own immune system fight cancer cells more effectively. Others might receive RO7496353 with a checkpoint inhibitor and standard chemotherapy, or just with standard chemotherapy, depending on what the doctors think is best for them and the study plan.
This is an early-stage study, sometimes called a 'Phase I' study. This means it's one of the first times this new medicine is being given to people. The main goal at this stage is to find a safe dose and understand how the medicine works in the human body, rather than to prove it cures cancer. The information we gather will help us decide if this treatment should be studied further.
Key takeaways
- Tests a new medicine (RO7496353) for advanced solid tumours.
- Aims to check safety and how the medicine works.
- May be combined with existing cancer treatments like immunotherapy or chemotherapy.
- This is an early, 'first-in-human' study.
- Open to adults 18 years and older with specific cancer types.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. There is no upper age limit. We are including both men and women.
The study is for people who have solid tumours that are considered 'locally advanced' (meaning they have grown into nearby tissues) or 'metastatic' (meaning the cancer has spread to other parts of the body). Your care team will be able to confirm if your specific cancer fits this description.
There will be other, more detailed criteria that your doctor will need to check. These include things like your general health, other medical conditions you might have, and any previous treatments you've received. These checks are important to make sure the study is safe for you and that the results will be clear.
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 solid tumour that is advanced or has spread?
- Are you able to attend appointments regularly?
- Are you generally well enough for this kind of treatment?
What does participation involve?
If you decide to take part in this study, you would begin by having several tests to see if you are suitable. These might include blood tests, scans, and physical examinations. If you qualify, you will receive the study treatment as planned by the research team. This could be RO7496353 alone, or in combination with other anti-cancer drugs.
You would need to attend regular clinic visits for check-ups, more blood tests, and scans to monitor your health and how the treatment is affecting you and your cancer. These visits would be more frequent at the start of the study. After the treatment phase, there will be a follow-up period where we continue to monitor your health for a certain amount of time, even if you are no longer taking the study medicine. The total duration of your participation, including treatment and follow-up, will vary but your study doctor will explain this in detail before you decide to join.
Potential risks and benefits
Locations (2)
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What does 'solid tumours' mean?
Solid tumours are cancers that form a lump or mass, unlike blood cancers like leukaemia.
What is a 'checkpoint inhibitor'?
It's a type of immunotherapy that helps your body's own immune system fight cancer cells more effectively.
Is this medicine a cure for cancer?
This is an early-stage study to find a safe dose and understand how the medicine works. It's not designed to prove a cure.
Will I know if I'm getting the new drug or a standard treatment?
The study design will explain this. Sometimes participants know, sometimes it's decided randomly, and sometimes a 'placebo' (dummy drug) is used, but this is usually explained clearly.
How long will I be in the study?
The time you spend in the study, including treatment and follow-up, will be clearly explained by your study doctor before you join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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