A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors
This research study is for adults with advanced or spreading cancers. It's one of the very first times a new medicine, called BGB-A3055, is being tested in people. Sometimes, it will be given on its own, and sometimes it will be given with another medicine called tislelizumab, which is already used to treat some cancers. The main goals are to check if the new medicine is safe and what side effects it might cause. Doctors also want to understand how the medicine works in the body and if it shows any signs of shrinking tumours. This is an early-stage study, meaning it helps doctors learn important information before testing it more widely.
At a glance
What is this study about?
This study is about a new medicine, BGB-A3055, that doctors hope could help people with advanced or spreading cancers. 'Advanced' means the cancer has grown and might have spread to other parts of the body. This is an early study, which means it's one of the first times this new medicine is being given to people. It's a very important step because it helps doctors learn crucial information before they can test it on more people.
The main things the doctors want to find out are how safe the new medicine is and whether it causes any side effects. They will also look at how your body handles the medicine – for example, how much of it gets into your blood and how quickly your body gets rid of it. Doctors will also check to see if the medicine has any early signs of helping to fight the cancer, perhaps by stopping it from growing or even making it shrink.
Sometimes, participants will receive BGB-A3055 on its own. Other times, it will be given together with another medicine called tislelizumab, which is already used to treat some cancers. Testing them together could help doctors see if this combination works better. The information gathered from this study will help decide if this new medicine is promising enough to be studied further in the future.
Key takeaways
- This is an early-stage study for a new cancer medicine.
- It's for adults with advanced or spreading solid tumours.
- The main aim is to check the medicine's safety and how it works in the body.
- Participants may receive the new medicine alone or with another cancer drug.
- Taking part means regular hospital visits for tests and treatment.
- You can stop participating at any time if you wish.
Who may be eligible?
This study is looking for adults aged 18 years and older who have advanced or spreading cancer. Both men and women can take part.
To be considered for the study, you would generally need to have a type of cancer that is advanced or has spread to other parts of your body. Your doctor will need to check your medical history and current health carefully to make sure the study might be suitable for you.
There will be other specific health checks and requirements to make sure it's safe for you to take part. For example, your doctor will need to review your overall health, including how well your liver and kidneys are working, and what other treatments you may have had. These checks are important to keep you safe.
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 a diagnosis of advanced or spreading solid tumour cancer?
- Are you able to attend regular hospital visits and follow study instructions?
- Are you willing to undergo various tests including blood tests and scans?
- Are you able to understand and ask questions about the study information?
What does participation involve?
If you decide to take part in this study, you would have regular visits to the hospital or clinic. These visits would involve various assessments, such as blood tests, physical examinations, and scans (like CT or MRI scans) to check your health and how the medicine is affecting your cancer. You would receive the study medicine, BGB-A3055 (either on its own or with tislelizumab), usually through an infusion (into a vein) or by mouth, depending on what the doctors decide is best. The exact schedule of doses and tests will be explained to you in detail. There will be a period of treatment, followed by regular check-ups to monitor your progress and any side effects. The total length of time you would be involved in the study can vary, but it would involve ongoing monitoring for some time.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
What does 'Phase 1' study mean?
Phase 1 means this is an early study, mainly to find out if a new medicine is safe for people and what dose to use.
What kind of cancer is this study for?
It's for people who have advanced or spreading types of solid tumours (cancers that form solid lumps, not blood cancers).
Will this medicine cure my cancer?
We don't know yet. This is a very early study to see if the medicine is safe and if it shows any early signs of helping fight cancer.
Do I have to take part?
No, taking part is completely your choice. Your decision will not affect your relationship with your doctor or the care you receive.
What happens if I get side effects?
The study team will closely monitor you for any side effects and provide appropriate care and support immediately.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.