RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

This research study is testing a new medicine called BGB-16673. We want to see how safe it is and how well it works when given alongside other treatments for people who have B-cell cancers. These are cancers that affect a type of white blood cell called B-cells. The study is for people whose cancer has either returned after previous treatment (relapsed) or hasn't improved with treatment (refractory). We are exploring different combinations of BGB-16673 with other drugs like Sonrotoclax, Zanubrutinib, Mosunetuzumab, and Glofitamab. The main goal is to understand if these combinations can help control the cancer while keeping patients safe.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

BeOne Medicines

Enrolment target

Start

27 Nov 2024

Estimated completion

02 Dec 2029

B-cell Malignancy Relapsed Cancer Refractory Cancer B-cell Lymphoma

What is this study about?

This study is an important step in finding new ways to treat certain blood cancers called B-cell malignancies. These are cancers that start in white blood cells called B-cells. Sometimes, despite treatment, these cancers can come back (this is called 'relapsed') or they might not respond to treatments given before (this is called 'refractory'). Because of this, doctors and researchers are always looking for new and better treatment options.

Here, we are investigating a new medicine called BGB-16673. We want to understand how safe it is when given to patients, and also how well it works against the cancer. Importantly, we’re not testing BGB-16673 on its own, but in combination with other existing medicines. The study is divided into different parts, or ‘substudies’, with each part trying out BGB-16673 with a different partner drug, such as Sonrotoclax, Zanubrutinib, Mosunetuzumab, or Glofitamab.

By carefully studying these combinations, we hope to learn more about their effects on the body – both positive and negative. The information we gather will help us figure out if these new approaches could become useful treatments for people living with B-cell malignancies in the future. The study is in early stages (Phases 1 and 2), meaning we are still exploring the best and safest ways to use these treatments.

Key takeaways

This study evaluates a new drug, BGB-16673, for specific B-cell cancers.
It focuses on cancers that have returned or haven't responded to previous treatments.
BGB-16673 is tested in combination with other known medicines.
The main goals are to check the safety and how well the combinations work.
It's for adults aged 18 and over.
Participants will have regular check-ups and monitoring.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) with a B-cell cancer that has either come back or not responded to previous treatments. Your cancer must be measurable, meaning doctors can track its size. You also need to be generally well enough to take part and have your organs (like kidneys, liver) working properly.

For women who could become pregnant, you would need to agree to use effective birth control during the study and for a period after your last dose of medication. Men who are able to have children would also need to use effective birth control during the study and for a period after their last dose. This is really important to prevent pregnancy during the trial.

There are also some reasons why you might not be able to join. For example, if you haven't received any treatment for your B-cell cancer yet, or if your cancer has spread to your brain or the fluid around it and isn't being controlled. If you've had another type of cancer in the last two years (other than the B-cell cancer being studied), you might also not be able to participate. Doctors will check all these details carefully to see if this study is suitable 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 a B-cell cancer that has come back or not responded to previous treatments?
Are you generally well enough to participate in a study?
Are your kidneys and other body organs working well?
If you are a woman who could become pregnant, are you willing to use effective birth control?
If you are a man who could have children, are you willing to use effective birth control?

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 study drug BGB-16673 along with one of the other mentioned medicines. You would have regular visits to the clinic for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. These visits help the doctors understand the treatment's safety and effectiveness.

The frequency of visits and tests would be scheduled by the study team. You would be given instructions on how to take your medication. The total commitment for the study, including treatment and follow-up, would depend on your response to the treatment and the specific substudy you are in. It's a journey where you'd be closely supported by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. You might not directly benefit from this study, but the information gained could help others with similar conditions in the future. The doctors will closely monitor you for any side effects or changes in your health. All medications, including those used in this study, can have side effects, and the study team will explain these to you. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (50)

Mayo Clinic Phoenix
Verified postcode
Phoenix, United States· Recruiting
University of Southern California Norris Comprehensive
Verified postcode
Los Angeles, United States· Recruiting
Mayo Clinic Jacksonville
Verified postcode
Jacksonville, United States· Recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
The University of Kansas Cancer Center
Verified postcode
Westwood, United States· Recruiting
Mayo Clinic Rochester
Verified postcode
Rochester, United States· Recruiting
Washington University School of Medicine
Verified postcode
St Louis, United States· Recruiting
Summit Medical Group
Verified postcode
Florham Park, United States· Recruiting
Icahn School of Medicine At Mount Sinai
Verified postcode
New York, United States· Recruiting
Columbia University Medical Center
Verified postcode
New York, United States· Recruiting
Weill Cornell Medical College Newyork Presbyterian Hospital
Verified postcode
New York, United States· Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
Verified postcode
New York, United States· Recruiting

Common questions

What is a 'B-cell malignancy'?

It's a type of cancer that starts in certain white blood cells called B-cells. These cells are part of your immune system.

What does 'relapsed or refractory' mean?

Relapsed means the cancer has come back after treatment. Refractory means the cancer didn't respond well to previous treatments.

Is BGB-16673 a new medicine?

Yes, BGB-16673 is a new investigational drug being tested in this study.

Will I get this new medicine on its own?

No, BGB-16673 will be given in combination with another established medicine in this study.

How long would I be on the study?

The full duration of your participation, including treatment and follow-up, will be discussed with you by the study team, as it can vary based on your response and the specific part of the study you join.

How to find out more

Study Director

clinicaltrials@beonemed.com 1.877.828.5568 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.