A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
This research study is looking at a new medicine called BGB-16673 for a group of blood cancers known as B-cell malignancies, which include different types of lymphoma and chronic lymphocytic leukaemia. The study has two main parts. The first part aims to find the safest and most effective dose of BGB-16673. The second part will then use this dose to further test the medicine in more people, to understand better how it works and what side effects it might have. Researchers are trying to see if this new medicine could be a helpful treatment option for these conditions. It's important to remember this is an early-stage trial, so more research will be needed.
At a glance
What is this study about?
This study is exploring a new medicine called BGB-16673, which is being investigated as a possible treatment for several types of B-cell cancers. B-cell cancers are a group of conditions that affect a specific type of white blood cell, including different forms of lymphoma (like follicular lymphoma or mantle cell lymphoma) and chronic leukaemias (like chronic lymphocytic leukaemia, or CLL).
The study is split into two main sections. The first part, called Phase 1, is like a careful exploration. Researchers will give different doses of BGB-16673 to a small number of people to find out which dose is the safest and most likely to work, while keeping side effects manageable. They'll start with very low doses and gradually increase them, all while closely monitoring the participants.
Once a good dose is found, the study moves into the second part, Phase 2. Here, more people with these B-cell cancers will receive the chosen dose. This larger group helps researchers get a clearer picture of how effective the medicine is, what side effects might occur, and if it could be a valuable treatment option in the future. Because this is an early-stage study, it's about gathering important initial information on a new medicine.
Key takeaways
- Tests new medicine BGB-16673 for B-cell cancers.
- Aims to find best dose and check safety/effectiveness.
- Includes various lymphomas and leukaemias.
- Usually for people who've had previous treatments.
- Early-stage research, not a guaranteed cure.
- Participation is voluntary; you can stop at any time.
Who may be eligible?
To join this study, you would need to have certain types of B-cell cancer, such as Marginal Zone Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma, Waldenström Macroglobulinemia, or Diffuse Large B-cell Lymphoma that has come back or not responded to previous treatments.
Often, participants must have already received a medicine called a BTK inhibitor. If you have, you usually need to have been on it for at least 8 weeks, unless you had to stop sooner because of side effects. You might also be eligible if your cancer progressed while on a BTK inhibitor or after finishing treatment, or if you had to stop it due to side effects.
Another important factor is your general health and how well you can go about your daily activities. This is often checked using a score called ECOG Performance Status, and for this study, you would need to have a score of 0, 1, or 2, which means you are generally active or can do light tasks.
- Do I have one of the listed B-cell cancers (e.g., Follicular Lymphoma, CLL, MZL, MCL, WM, DLBCL)?
- Have I had prior treatment for my cancer, specifically a BTK inhibitor, if applicable to my diagnosis?
- Is my general health good enough to participate in a study (ECOG 0-2)?
- Am I aged 18 or over?
- Has my cancer either come back or not responded well to previous treatments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll be receiving a new medicine called BGB-16673. Initially, the study will involve finding the right dose, which means you might be among the first to receive a certain dose level. You will have regular hospital visits for check-ups, blood tests, and scans (like X-rays or CT scans) to monitor your health and how the treatment is working. The study team will explain how and when you'll take the medicine.
Throughout your time in the study, doctors and nurses will closely watch you for any side effects and changes in your cancer. This means frequent appointments, especially at the beginning. The total duration of your participation in the study and how often you need to attend clinic visits will depend on how you respond to the treatment and the stage of the study you are in. You will also have follow-up checks even after you stop taking the study medicine. You can stop participating at any time if you wish to, with careful discussion with the study team.
Potential risks and benefits
Locations (130)
- University of Alabama At Birmingham HospitalBirmingham, United States· Recruiting
- Mayo Clinic PhoenixPhoenix, United States· Completed
- Honor Health Research InstituteScottsdale, United States· Recruiting
- University of Arizona Cancer CenterTucson, United States· Recruiting
- University of California San Diego (Ucsd) Moores Cancer CenterLa Jolla, United States· Recruiting
- Stanford MedicinePalo Alto, United States· Recruiting
- UCLA Santa Monica Cancer CareSanta Monica, United States· Recruiting
- Uchealth NorthFort Collins, United States· Recruiting
- Mayo Clinic JacksonvilleJacksonville, United States· Recruiting
- Mount Sinai Medical Center Braman Comprehensive Cancer CenterMiami, United States· Recruiting
- Tampa General Hospital Cancer InstituteTampa, United States· Recruiting
- Augusta UniversityAugusta, United States· Recruiting
+118 more sites — see the official record for the full list.
Common questions
What kind of conditions is this study investigating?
This study is looking into several types of B-cell cancers, including various lymphomas like Follicular Lymphoma and Mantle Cell Lymphoma, and chronic leukaemias like Chronic Lymphocytic Leukaemia.
What is BGB-16673?
BGB-16673 is a new investigational medicine that researchers are hoping could help treat certain B-cell cancers. It is still being tested in clinical trials.
What does 'Phase 1' and 'Phase 2' mean in a study?
Phase 1 is the first stage where they test a new medicine in people to find a safe dose and see how the body handles it. Phase 2 then tests that dose in more people to see how well it works and if there are common side effects.
Do I need to have had previous treatment to join?
For many parts of this study, especially if you have certain types of cancer, you would need to have received previous treatment for your cancer, often including a type of medicine called a BTK inhibitor.
Can I leave the study if I change my mind?
Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, without it affecting your routine medical care.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
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