RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

This study is an early-stage clinical trial (Phase 1) looking into a new medication called RO7566802. It will be given alone and in combination with another drug, atezolizumab, to people with solid tumours that are locally advanced, have come back, or have spread to other parts of the body. The main goal is to understand how safe the new treatment is, how patients tolerate it, and how it moves through the body. Researchers will also look for early signs that the treatment might be working against the cancer. This is a "first-in-human" study, meaning it's one of the first times this new drug is being tested in people. Participants will be carefully monitored throughout the study.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Genentech, Inc.

Enrolment target

250

Start

27 Nov 2023

Estimated completion

31 Dec 2027

Locally Advanced Solid Tumors Recurrent Solid Tumors Metastatic Solid Tumors

What is this study about?

This study is a clinical trial, which means it's a carefully planned medical research study involving people. The main purpose of this particular study is to learn more about a new medicine, RO7566802. It's an early-stage study (called Phase 1), which means researchers are primarily focused on understanding how safe the drug is and if people can tolerate it. They also want to see how the new medicine behaves in the body, such as how it's absorbed and processed, and if it causes an immune response.

The study involves people who have solid tumours that are advanced, have come back, or have spread. These are types of cancer that may have become more difficult to treat with standard therapies. The new medicine, RO7566802, will be tested on its own and also in combination with an existing cancer drug called atezolizumab. By doing this, researchers hope to see if the combination of drugs might be more effective.

While the main focus is on safety and how the new medicine works, researchers will also be looking for any early signs that the treatment might be helping to shrink the tumours or slow their growth. The information gathered from this study is crucial for deciding if this new medicine should be studied further in larger trials.

Key takeaways

This is an early-stage (Phase 1) trial for advanced solid tumours.
The study is testing a new drug, RO7566802, alone and with atezolizumab.
Main goals are to check safety, how the drug works, and early signs of effectiveness.
Participants must have generally good health and specific cancer types.
You'll have regular hospital visits for treatment and monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to have certain types of solid tumours that are either locally advanced, have returned, or have spread. These cancers should have already been treated with standard methods, or standard treatments haven't worked well, weren't tolerated, or aren't suitable for you. You must also be generally well enough to take part, meaning you can look after yourself for most of the day, and your important organs (like your liver and kidneys) are working properly. Your doctor would assess your overall health and expect you to live for at least three more months. For some parts of the study, doctors will need to be able to measure your tumour.

There are also reasons why you might not be able to join. For example, if you've had anti-cancer treatment (like chemotherapy or radiotherapy) in the last three weeks, or if you have certain active infections like hepatitis B or C, tuberculosis, or HIV. The study also excludes people who have had certain vaccines recently, have uncontrolled pain from their cancer, or have serious heart conditions. If you have active autoimmune diseases or brain metastases that are causing symptoms, you would also not be eligible.

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.

Do you have a solid tumour that is advanced, has come back, or has spread?
Have standard cancer treatments already been tried for your condition, or are they not suitable?
Are you generally well and able to mostly look after yourself?
Are your major organs (like liver, kidneys) working properly?
Have you avoided other cancer treatments (chemotherapy, radiation) in the last three weeks?
Do you not have certain serious infections like active hepatitis B/C or HIV?

Answer every question to see your result.

What does participation involve?

This study is divided into two main parts: a dose-escalation phase and an expansion phase. In the dose-escalation phase, a small group of participants will receive increasing doses of the new drug to find the safest and most effective amount. In the expansion phase, more participants will receive the dose found to be best. You would receive the study medication (RO7566802, either alone or with atezolizumab) as an infusion. This would involve regular visits to the clinic for treatments, blood tests, and scans to monitor your health and the size of your tumour. The study team will explain the exact schedule of visits and tests, which will depend on which part of the study you are in. The total duration of your participation would be discussed with you by the research team.

Potential risks and benefits

Like all clinical trials, there are potential benefits and potential risks to consider. A potential benefit could be access to a new treatment that isn't yet widely available, which might help control your cancer if current treatments haven't worked or aren't suitable. However, as this is an early-stage study, we don't know for sure if the treatment will be effective, and there's a chance it may not help your specific condition. There are also risks associated with taking any new medicine, including side effects that could be mild or more serious. The study team will closely monitor you for any side effects and will explain all known risks before you make a decision. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

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

University of Alabama at Birmingham (UAB)
Verified postcode
Birmingham, United States· Recruiting
Yale Cancer Center
Verified postcode
New Haven, United States· Recruiting
Icahn School of Medicine at Mount Sinai (ISMMS)
Verified postcode
New York, United States· Recruiting
The Ohio State University
Verified postcode
Columbus, United States· Recruiting
Magee-Woman's Hospital
Verified postcode
Harrisburg, United States· Recruiting
SCRI Oncology Partners
Verified postcode
Nashville, United States· Recruiting
St Vincent's Hospital Sydney
Verified postcode
Darlinghurst, Australia· Recruiting
Peter Maccallum Cancer Centre
Verified postcode
Melbourne, Australia· Recruiting
British Columbia Cancer Agency - 600 10th Ave W
Verified postcode
Vancouver, Canada· Recruiting
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting
National University Hospital
Verified postcode
Singapore, Singapore· Recruiting
National Cancer Centre
Verified postcode
Singapore, Singapore· Recruiting

Common questions

What kind of cancer is this study for?

This study is for people with solid tumours that are advanced, have come back, or have spread to other parts of the body.

What are they testing in this study?

They are testing a new medicine called RO7566802, both by itself and together with another cancer drug called atezolizumab.

What does 'Phase 1' mean?

Phase 1 means it's an early-stage study focused on finding out if the new medicine is safe, what side effects it might have, and how it works in the body.

Will I get the new drug?

If you join the study and meet all the requirements, you would receive the new drug, either by itself or with atezolizumab. This is not a placebo-controlled trial.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. It won’t affect your normal medical care.

How to find out more

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. Only) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.