Active not recruitingPHASE1INTERVENTIONAL

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

This research study is investigating a new medication, Runimotamab, for individuals diagnosed with advanced or metastatic cancers that have a specific marker called HER2. These are cancers that have spread or are difficult to treat. The main goals are to understand if Runimotamab is safe, how well people tolerate it, and how it behaves in the body. Researchers will be testing Runimotamab on its own and in combination with another established cancer treatment called Trastuzumab. This is the first stage of testing (Phase 1), which focuses on safety before moving to larger studies.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Genentech, Inc.

Enrolment target

123

Start

06 Jun 2018

Estimated completion

30 Nov 2027

Solid Tumors

What is this study about?

This clinical trial is designed to investigate a new medication called Runimotamab. It's for people who have certain types of cancer that have spread or are at an advanced stage and have a particular characteristic known as 'HER2 expression'. HER2 is a protein found on the surface of some cancer cells that can make them grow and divide more quickly. By understanding how Runimotamab affects these HER2-positive cancer cells, the researchers hope to develop better treatments in the future.

The study will look at how safe Runimotamab is for patients, how well their bodies handle it, and how much of the drug stays in the body over time. This information is crucial for understanding its potential as a treatment. Researchers will also be looking at Runimotamab by itself and in combination with another medicine, Trastuzumab, which is already used to treat HER2-positive cancers. Combining treatments can sometimes be more effective than using one alone.

This is a 'Phase 1' study, which means it's one of the first times this new medicine is being tested in people. The primary focus of Phase 1 studies is to ensure the treatment is safe and to find the right dose, rather than to see if it cures the cancer. However, any potential benefits will also be carefully monitored.

Key takeaways

This is an early-stage study (Phase 1) looking at a new drug for advanced HER2-positive cancers.
The main goals are to check the drug's safety, how it's tolerated, and how it works in the body.
Runimotamab will be tested alone and with another common cancer drug, Trastuzumab.
Eligibility depends on your general health and specific characteristics of your cancer.
Participation involves receiving the study drug and regular health check-ups.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, your general health needs to be good enough to participate in a clinical trial. This means your heart, blood, and other major organs should be working well, and you should be able to carry out your normal daily activities without too much difficulty. Any side effects from previous treatments must have settled down.

Specifically, you must have a cancer that has spread or is advanced and has the HER2 marker. For breast cancer, it needs to be HER2-positive and have either come back or not responded to standard treatments. If you have stomach or gullet (gastric/gastroesophageal) cancer, it also needs to be HER2-positive and have progressed despite prior treatments, including trastuzumab and certain types of chemotherapy.

There are also reasons why you wouldn't be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant, you cannot take part. People with significant heart, lung, or liver problems, or certain types of hepatitis, 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 I have a HER2-positive cancer that is advanced or has spread?
Is my general health good enough, meaning I can manage daily activities and my major organs are working well?
Have any side effects from my previous cancer treatments mostly settled down?
Am I not pregnant or breastfeeding, and not planning to become pregnant during or shortly after the study?
Do I meet the specific requirements concerning previous treatments for my type of HER2-positive cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study drug, Runimotamab, either on its own or with Trastuzumab, given directly into a vein (intravenously). You would have regular appointments at the study clinic for assessments, which might include blood tests, scans, and physical examinations, to monitor your health and how the treatment is affecting you. The total duration of your participation in the study is not specified in detail here, but these types of studies typically involve an initial treatment period followed by a long-term follow-up to track your progress. You will receive detailed information about the schedule of visits and procedures if you are considered for the study.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it is widely available, and your health will be closely monitored by a dedicated medical team. However, there are also potential risks, as Runimotamab is an investigational drug and its side effects are not yet fully known. You might experience side effects from the treatment, and it's possible that the treatment may not be effective for your condition. You are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (27)

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

Yale University
Verified postcode
New Haven, United States
Washington University
Verified postcode
Saint Louis, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
SCRI Oncology Partners
Verified postcode
Nashville, United States
MD Anderson Cancer Center
Verified postcode
Houston, United States
Peter MacCallum Cancer Centre
Verified postcode
Melbourne, Australia
Grand Hopital de Charleroi asbl
Verified postcode
Charleroi, Belgium
Princess Margaret Hospital
Verified postcode
Toronto, Canada
Rigshospitalet-Blegdamsvej 9
Verified postcode
Copenhagen, Denmark
EDOG - Institut Bergonie - PPDS
Verified postcode
Bordeaux, France
Centre Léon Bérard
Verified postcode
Lyon, France
Gustave Roussy
Verified postcode
Villejuif, France

Common questions

What does 'HER2-expressing' mean for my cancer?

It means your cancer cells have a specific protein called HER2 on their surface. This is identified through tests on your tumour sample.

What is Runimotamab?

Runimotamab is a new investigational drug being studied. It's not yet approved for general use and its effects on the body are still being explored.

Why is this called a 'Phase 1' study?

Phase 1 studies are the first step in testing a new drug in humans. The main goal is to check its safety and find a suitable dose, not primarily to see if it's a cure.

Will I receive other cancer treatments during this study?

You will receive Runimotamab, either alone or sometimes in combination with Trastuzumab, which is an established cancer treatment. Other existing cancer treatments are generally not used alongside the study drug.

Can I stop participating in the study if I change my mind?

Yes, absolutely. Your participation is voluntary, and you can withdraw from the study at any time without giving a reason, and it won't affect your future medical care.