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

To Study the Safety and Pharmacokinetics of BLYG8824A in Patients with Locally Advanced or Metastatic Colorectal Cancers

This study is about a new medicine, BLYG8824A, for people who have bowel cancer that is advanced or has spread to other parts of the body. This is a very early-stage study, meaning it's the first time this new medicine is being tested in humans. The main goals are to check if the medicine is safe and to understand how it behaves in the body. For example, how much should be given, how long it stays in the body, and if it causes any side effects. This kind of research helps scientists know if a new medicine can be studied further in the future to see if it could help treat cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Genentech Inc.

Enrolment target

Start

30 Jul 2024

Locally Advanced or Metastatic Colorectal Cancers (mCRC)

What is this study about?

Imagine you or someone you know has been diagnosed with bowel cancer that has either spread to other parts of the body (this is called metastatic) or is quite advanced locally. Doctors are always looking for new and better ways to treat these conditions. This particular study is about testing a brand-new medicine, which for now is called BLYG8824A, to see if it could be a helpful treatment in the future.

This is a very early step in testing new medicines, often called a 'Phase I' study. Think of it like taking a brand-new car for its very first test drive. We're not yet checking how well it races, but rather if all the basic parts work safely and if we understand how it runs. In this study, doctors want to find out two main things: first, is this medicine safe for people to take? And second, how does it act inside the human body? This includes understanding how much of the medicine needs to be given and how the body processes it.

By carefully studying these things, researchers can decide if the medicine is promising enough to continue testing in larger studies, which would then look at whether it actually helps treat the cancer. It's a crucial first stage to make sure any new treatment is as safe as possible before moving on to see how effective it might be.

Key takeaways

This is a first-time-in-humans study for a new bowel cancer medicine (BLYG8824A).
Its main goals are to check the medicine's safety and how it works in the body.
It's for adults (18+) with advanced or metastatic bowel cancer.
Participation involves close monitoring, regular visits, and tests.
There are potential unknown risks, as it's a new medicine.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to be an adult, at least 18 years old. People of any gender can take part.

The study is specifically for individuals who have been diagnosed with bowel cancer that is either locally advanced (meaning it has grown quite a bit in the area where it started) or has spread to other parts of the body (this is called metastatic cancer).

There might be other health checks or requirements that the study doctors will go through with you. These are in place to make sure the study is as safe as possible for everyone involved and that the results are 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?
Have you been diagnosed with bowel cancer that is advanced or has spread?
Are you able to attend regular hospital/clinic visits?
Are you willing to potentially receive a new, untested medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, BLYG8824A. Since this is the first time it's given to humans, you would be closely monitored by the study team, especially during the first few doses. This would involve regular visits to the hospital or clinic, where doctors and nurses would check your health, take blood samples, and ask about any side effects you might be experiencing.

The specific number of visits and tests would be detailed by the study team, but generally, early-stage studies involve frequent check-ups. You would also have regular examinations to see how you are doing. The total time you spend in the study would depend on how your body reacts to the medicine and the study's specific plan, which could last for several months.

Potential risks and benefits

Taking part in a study like this means you would be among the first people to receive a new medicine, which could potentially mean you are helping to advance medical knowledge and future treatments for bowel cancer. However, at this early stage, we don't yet know if the medicine will help your cancer. There's also a chance you could experience side effects that haven't been seen before, as the medicine is new. The study team will explain all known or potential risks to you in detail. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What does 'Locally Advanced or Metastatic Colorectal Cancers' mean?

It means bowel cancer that has either grown significantly in the area where it started or has spread to other parts of the body, like the liver or lungs.

What does 'Human Pharmacology (Phase I)' mean?

It means this is the very first time the new medicine is being given to people. The main goals are to check if it's safe and how the body handles it, not yet to cure the disease.

Will I get better if I join this study?

This study is mainly about safety and understanding the medicine. While it's hoped that new medicines will eventually help, we don't know yet if BLYG8824A will directly benefit your cancer at this early stage.

What kind of tests will I have?

You can expect regular health checks, blood tests, and possibly scans to monitor your health and see how the medicine is working in your body and if you have any side effects.

Can I stop the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.