Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Study to Evaluate Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Tumors

This is an early-stage research study for people with advanced cancers. Doctors are testing a new medicine, called RO7198457. They want to find out if it's safe to use in people and how long it stays in the body. They are testing RO7198457 by itself and also combined with another cancer medicine called Atezolizumab. Because it's an early study, it's the first time this new medicine is being given to people. The main goal is to understand any side effects and how the body handles the medicine, which helps doctors decide if it could be a useful treatment in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Genentech Inc.

Enrolment target

Start

28 Aug 2024

Advanced tumors

What is this study about?

This study is a very early step in testing a new medicine for cancer, called RO7198457. It's often called a 'Phase I' study. In this phase, the main goal is to see if the new medicine is safe for people to take, what side effects it might cause, and how the body deals with it. Researchers also want to find the right amount of medicine to give.

The medicine is being tested in people who have advanced cancer. This means their cancer has grown or spread beyond where it started. The study will look at the new medicine on its own and also in combination with another approved cancer medicine called Atezolizumab. Combining medicines can sometimes make treatments more effective.

Even though this is an early study and we don't know yet if the medicine will help treat cancer, understanding its safety and how it works in the body is a really important first step. This information helps doctors decide if the medicine should be studied further in larger groups of people.

Key takeaways

It's an early study (Phase I) of a new cancer medicine.
The main goals are to check safety and how the medicine works in the body.
It's for adults (18+) with advanced cancers.
The medicine (RO7198457) is tested alone and with another drug, Atezolizumab.
Participation helps future cancer research, but direct benefit is not guaranteed.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be an adult, 18 years old or older. The study is open to both men and women.

Because this is a study for advanced cancers, you would need to have cancer that has either spread or grown significantly. The research team will review your specific cancer details to see if they fit the study's requirements.

There will be other health requirements and possibly recent treatments you've had that the doctors will need to check. These are in place to make sure the study is safe for you and that the results are clear.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of advanced cancer?
Are you able to attend regular hospital or clinic visits?
Are you willing to potentially receive either the new medicine alone or in combination?
Are you willing to have blood tests and other assessments during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive the study medicine, RO7198457, which might be given alone or with Atezolizumab. You would have regular visits to the clinic to monitor your health, check for any side effects, and see how the medicine is working. These visits might include blood tests, scans, and physical examinations.

The total amount of time you would be involved in the study can vary. It depends on how you respond to the treatment and what the study doctors decide is best for your care. There would also be follow-up appointments after you stop taking the study medicine to make sure you remain well and to collect any lasting information.

Potential risks and benefits

Potential benefits from taking part in an early-stage study like this are not guaranteed. While you might not directly benefit from the new medicine, your participation could help doctors learn more about advanced cancer and contribute to finding new treatments for others in the future. As with any new medicine, there are potential risks, including unexpected side effects. The study team will explain all known risks and closely monitor you for any problems. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

—
Germany
—
Belgium

Common questions

What does 'advanced tumors' mean?

It means the cancer has grown or spread beyond where it started.

Is this a new medicine?

Yes, RO7198457 is a new experimental medicine, and this is its first time being used in people.

What is Atezolizumab?

Atezolizumab is an existing cancer medicine that works by helping your body's immune system fight cancer.

Will this study cure my cancer?

This is a very early study to test safety, not to find a cure. There is no guarantee of direct benefit for your cancer.

How long will the study last?

The length of time you'd be involved can vary depending on your response and the study plan, but the team will discuss this with you.