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

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the DGKζ Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab, in Patients With Advanced or Metastatic Solid Tumors

This study is looking into a new treatment called BGB-30813 for people who have advanced or metastatic solid tumours. This means cancers that have spread from where they started. Sometimes, BGB-30813 will be given on its own, and sometimes it will be given together with an existing cancer medicine called tislelizumab. The main goal is to check if the new treatment is safe and how well people tolerate it. Researchers will also learn how the body handles the medicine and look for early signs that it might help shrink tumours. This is one of the very first times this new medicine is being tested in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Beigene Ltd.

Enrolment target

Start

04 Sep 2023

Advanced or metastatic solid tumors

What is this study about?

This study is focused on a new medicine called BGB-30813. It's being tested for the first time in people who have advanced or metastatic solid tumours, which are cancers that have spread from their original location. The research aims to understand several important things about this new drug. Researchers will carefully check for any side effects and how well people tolerate the treatment, both when BGB-30813 is given alone and when it's combined with another anti-cancer drug called tislelizumab.

They also want to learn how the medicine moves through the body, how long it stays there, and how it affects the body's systems. This helps them work out the best dose. Importantly, the study will look for early signs that the treatment might be effective against cancer, such as shrinking tumours.

This type of study is called a Phase 1a/1b study. It's an early stage in testing new medicines and is crucial for gathering initial safety information and understanding how a drug works before it can be studied in larger groups of people. The information gathered here will help decide if this new medicine should be studied further as a potential cancer treatment.

Key takeaways

This study is testing a promising new treatment, BGB-30813, for advanced solid tumours.
It's an early-stage study (Phase 1) focused on safety and how the new drug works.
The treatment may be given alone or with an existing cancer medicine.
Participants will be closely monitored for side effects and any anti-cancer effects.
It offers access to an experimental treatment not yet widely available.

Who may be eligible?

To join this study, you must be at least 18 years old. The study is open to both men and women. You will need to have a type of cancer that has spread or is considered advanced (known as advanced or metastatic solid tumours).

There might be other health requirements or previous treatments that could affect whether you can join. These details would be discussed fully by the study team and your doctor.

It's important that your doctor involved in your care discusses your specific situation with the study team to see if this trial is a good fit 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 type of cancer that has spread or is considered advanced?
Are you able to attend regular hospital or clinic appointments?
Are you comfortable potentially trying a new, experimental medicine?
Do you have a doctor who is willing to discuss this trial with you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of tests and checks to make sure the study is right for you. This might include blood tests, scans, and physical exams. If you're eligible, you would receive the study medicine, BGB-30813, either on its own or with tislelizumab, depending on the study group you're assigned to.

You would have regular visits to the hospital or clinic for further tests, to receive your medication, and to check on your health and any side effects. These visits will vary in frequency but are usually more often at the beginning of the study. The study team will monitor your progress closely.

After you finish the treatment part of the study, there will likely be follow-up appointments to continue monitoring your health over a longer period. The total length of your participation would depend on your individual response and the study plan, but early phase studies often involve several months of active treatment and follow-up.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive a new, experimental treatment that isn't yet widely available. While the main aim of this early-stage study is to understand safety, there's always a possibility that the treatment could help reduce your cancer. However, as with all medicines, especially new ones, there's a risk of side effects, some of which could be serious or unexpected. The research team will carefully monitor you for any reactions. Remember, you have the right to withdraw from 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 kind of cancer is this study for?

This study is for people with advanced or metastatic solid tumours, meaning cancers that have spread from their original site.

Is this a new medicine?

Yes, BGB-30813 is a new medicine being tested in people for the first time.

What are they hoping to learn?

Researchers want to find out if the new medicine is safe, how the body handles it, and if it shows any early signs of helping fight cancer.

Will I get the new medicine or a standard treatment?

You will receive the new medicine, BGB-30813, either on its own or combined with an existing cancer drug, tislelizumab. This study isn't comparing it to a standard treatment or a placebo.

How long will the study last for me?

The length of your participation will depend on your individual response and the study's plan, but early studies often involve several months of treatment and follow-up.