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

A Phase 1 Study of BGB-B3227 Alone and in Combination With Tislelizumab in Patients With Advanced or Metastatic Solid Tumors

This research is a 'Phase 1' study looking at a new medicine called BGB-B3227. It's for adults who have solid tumours that are advanced or have spread. In some cases, BGB-B3227 will be given on its own, and in others, it will be given together with an existing medicine called tislelizumab. The main goal of this early-stage study is to understand if BGB-B3227 is safe for people to take and to learn how it behaves in the human body. Because it's a Phase 1 study, it's one of the first times this new medicine is being tested in people. Researchers will be carefully checking for any side effects and how the body reacts to the treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

BeOne Medicines AG

Enrolment target

Start

11 Dec 2024

Solid tumors

What is this study about?

This study is a very early step in checking a new medicine called BGB-B3227 for people with advanced solid tumours. "Solid tumours" are growths like those found in breast, lung, or bowel cancer, rather than blood cancers like leukaemia. "Advanced" means the cancer has grown or spread.

In this study, the new medicine BGB-B3227 will be given either by itself or sometimes with another medicine called tislelizumab, which is already used to treat some cancers. This is a "Phase 1" study, which means it's one of the very first times this specific new medicine is being given to people. The main aim is to see if it's safe and to understand what dose works best, not primarily to see if it cures cancer at this stage.

Taking part in this kind of study helps doctors learn a lot about new treatments. This information is really important because it helps decide if the treatment should move on to bigger studies. If successful, new treatments could offer more options for people with cancer in the future.

Key takeaways

This is an early-stage (Phase 1) study for a new cancer medicine.
It's for adults with advanced solid tumours that have grown or spread.
The main purpose is to check the medicine's safety and how it works in the body.
The new medicine (BGB-B3227) might be given alone or with another drug (tislelizumab).
Participation involves regular hospital visits for tests and treatment.
You can stop participating in the study at any time.

Who may be eligible?

To be able to join this study, you must be 18 years old or older. The study is open to both men and women.

"Advanced or metastatic solid tumours" means you have a type of cancer that started as a solid lump (like in the breast, lung, or bowel) and it has grown or spread to other parts of your body, and standard treatments haven't worked or are no longer suitable for you.

There will be other health checks to make sure this study is safe for you. For example, doctors will need to make sure your liver, kidney, and blood are working well enough for you to take part. They will also check if you have other serious health problems that might make the new medicine risky for you.

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 advanced or spread solid tumours?
Are you able to attend regular hospital visits for treatment and check-ups?
Are you comfortable with receiving an experimental drug that doctors are still learning about?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will likely need to make regular visits to the hospital or clinic. These visits will involve blood tests, physical examinations, and scans to see how your body is reacting to the medicine and to check the tumour. You will be given the study medicine, either BGB-B3227 alone or with tislelizumab, possibly through an IV drip or as tablets. The exact schedule will be explained by the study team.

Doctors and nurses will closely monitor you for any side effects and to see how the treatment is working. The total time you spend on the study will depend on how you respond to the treatment and the study plan, but it could involve several months of regular visits, with follow-up calls or visits after your treatment phases are complete. You'll be given a clear schedule and all instructions if you choose to participate.

Potential risks and benefits

Potential downsides of joining include experiencing new side effects from the experimental medicine, which can be mild or serious. There's also no guarantee that the new medicine will help your cancer. On the potential upside, you might get access to a new treatment before it's widely available, and your participation helps doctors learn more about cancer, which can benefit future patients. It's important to remember that you have the right 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
Italy

Common questions

What does 'Phase 1' mean?

Phase 1 means this is one of the first times this new medicine is being tested in people. The main aims are to test its safety and how it acts in the body.

What are 'solid tumours'?

Solid tumours are lumps of cells that can grow in different parts of the body, such as the breast, lung, or bowel, unlike blood cancers.

Will this medicine cure my cancer?

At this early stage, the study's main goal is to check safety and how the medicine works, not to cure cancer. There's no guarantee the treatment will work for you.

What is tislelizumab?

Tislelizumab is another medicine that is already used to treat some cancers. In this study, it may be given alongside the new medicine.

Can I leave the study if I change my mind?

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