AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A study evaluating the safety, tolerability, pharmacokinetics, and activity of RO7566802 given alone and in combination with atezolizumab in patients with locally advanced or metastatic solid tumor malignancies

This research study is testing a new medicine called RO7566802. It's being given to adult patients who have solid tumours that have grown locally or spread to other parts of the body. The study will look at how safe the new medicine is, how well people can tolerate it (meaning, what side effects they might have), and how the body uses and gets rid of it. Researchers also want to see if the medicine shows any early signs of helping to treat the cancer. Some patients will get RO7566802 on its own, while others will get it alongside another existing cancer medicine called atezolizumab. This is an early-stage study, meaning it's one of the first times this new medicine is being given to people.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Genentech Inc.

Enrolment target

Start

18 Feb 2025

Locally Advanced or Metastatic Solid Tumors

What is this study about?

This study is about exploring a new experimental medicine, RO7566802, for people with solid tumours that are advanced or have spread. Solid tumours are growths of abnormal cells in organs like the breast, lung, or bowel, unlike blood cancers. The 'advanced' part means the cancer has grown into nearby tissues, and 'metastatic' means it has spread to other parts of the body.

The main reasons for doing this study are to carefully check if the new medicine is safe for people, how their bodies react to it, and what side effects might occur. Researchers will also be looking at how quickly the body absorbs the medicine, how it processes it, and how it eventually leaves the body. Another key goal is to see if there are any early indications that this new medicine could help treat the cancer.

In some parts of the study, patients will receive just the new medicine, RO7566802. In other parts, they might get RO7566802 combined with an existing cancer medicine called atezolizumab. Atezolizumab is a type of immunotherapy that helps your body's immune system fight cancer. This is one of the very first times this new medicine is being tested in humans, which is why it's called a 'Phase I' trial. These early studies are crucial for understanding new treatments before they can be tested more widely.

Key takeaways

This study is testing a new cancer medicine, RO7566802.
It's for adults with advanced or spreading solid tumours.
The main goals are to check if the new medicine is safe and how the body handles it.
Some patients will get the new medicine alone, others will get it with an existing drug (atezolizumab).
This is an early-stage study (Phase I).
Regular hospital visits and health checks will be part of taking part.

Who may be eligible?

This study is open to both men and women who are aged 18 years or older. There is no upper age limit for taking part.

To be considered for this study, you must have a solid tumour that is either locally advanced (meaning it has grown significantly in one area) or metastatic (meaning it has spread to other parts of your body). The medical team running the study will carefully check your full medical history and current health to make sure that taking part is suitable and safe for you.

There will be other, more specific health requirements that your doctor and the study team will review. These usually include things like specific types of cancer, particular test results, and whether you've tried other treatments before. They will explain all these details to you to determine if you can join 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 18 years old or older?
Do you have a solid tumour that is advanced or has spread?
Are you able to attend regular hospital appointments?
Are you willing to undergo regular medical tests like blood tests and scans?
Are you prepared to consider an experimental medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital or clinic. These visits will involve various checks to monitor your health, such as physical exams, blood tests, and scans (like CT or MRI scans) to see how your cancer is responding and to look for any side effects. You will receive the study medicine, RO7566802, which might be given alone or with atezolizumab, according to the study plan. The way the medicine is given (e.g., as pills or through a drip) and how often will be explained in detail.

The study will involve several cycles of treatment, and doctors will carefully track your progress throughout. After you finish the treatment part of the study, there will be a follow-up period where you'll have appointments to continue monitoring your health and any long-term effects of the medicine. The total duration of your participation, including both treatment and follow-up, will be clearly outlined by the study team before you begin.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from receiving a new experimental treatment that is not yet widely available, and your participation will help advance medical knowledge for others. However, as this is a new medicine, there could be side effects that are not yet fully known or understood. While the study team will monitor you closely for any reactions, some side effects could be serious. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Czechia

Common questions

What is a 'solid tumour'?

A solid tumour is a mass of abnormal cells that forms in organs like the breast, lung, or bowel. It's different from blood cancers like leukaemia.

What does 'locally advanced or metastatic' mean?

Locally advanced means the cancer has grown into nearby tissues. Metastatic means the cancer has spread from where it started to other parts of the body.

What is a Phase I study?

A Phase I study is one of the first times a new medicine is given to people. Its main purpose is to check for safety, how the body handles it, and to find the right dose.

Will I definitely get the new medicine?

If you join this study, you will receive either the new medicine (RO7566802) on its own or in combination with atezolizumab. You will not receive a placebo (dummy medicine).

What is atezolizumab?

Atezolizumab is a type of immunotherapy, a medicine that helps your body's own immune system find and fight cancer cells.