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

A Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038, a Pan-KRAS Inhibitor, as Monotherapy or in Combinations in Patients With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification

This research study is looking at a new medicine called BGB-53038. It's designed for people who have advanced or metastatic (spread) solid cancers with a particular genetic change known as a KRAS mutation or amplification. This is an early-stage study, meaning it's the very first time this drug is being tested in humans. The main goals are to understand if the drug is safe, how well people tolerate it, and how it moves through and affects the body. Researchers also want to see if the drug shows any early signs of shrinking tumours. Participants might receive the drug on its own or in combination with other treatments. This kind of study is crucial for developing new cancer therapies.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

BeOne Medicines AG

Enrolment target

Start

11 Apr 2025

Advanced or Metastatic Solid Tumors with KRAS Mutations or Amplifications

What is this study about?

This study is about a new potential medicine for certain types of advanced cancer. Our bodies are made of tiny building blocks called cells, and sometimes changes can happen within these cells, like a change in a gene. In this study, we're looking at cancers that have a specific change in a gene called 'KRAS'. When the KRAS gene changes or makes too many copies of itself, it can cause cancer to grow.

The new medicine, known as BGB-53038, is designed to specifically target these KRAS changes. This is exciting because it means the treatment could be more focused on the cancer cells, potentially leaving healthy cells alone. This study is an 'early phase' study, which means it's one of the very first times this medicine is being given to people. The main aim at this stage is to make sure it's safe to use.

We also want to understand how the medicine behaves once it's in the body – how much is absorbed, how long it stays there, and how it affects the cancer cells. This information is key to figuring out the best way to use the drug in the future. We'll also be looking for any early signs that the medicine is helping to control or shrink the cancer. This research is a really important step in trying to find new and more effective ways to treat cancers that have this KRAS gene change.

Key takeaways

This study is testing a new drug for advanced solid cancers with a specific genetic change (KRAS).
It's an early-stage study, mainly focused on drug safety in humans.
Participants must have a KRAS mutation or amplification in their cancer.
The drug aims to target these specific cancer-driving genetic changes.
You would be closely monitored by doctors and nurses if you choose to participate.

Who may be eligible?

To join this study, you would need to be an adult, at least 18 years old. Importantly, you would have to have been diagnosed with an advanced or metastatic solid tumour, which means a tumour that has either grown significantly or spread to other parts of your body.

A key requirement is that your cancer must have a specific genetic change, either a 'KRAS mutation' or 'KRAS amplification'. This would be checked by your medical team through special tests. The study is open to both men and women.

There will be other detailed medical checks to make sure the study is a safe option for you. These checks would look at your overall health, any other medical conditions you have, and other treatments you might be receiving. Your doctor would help determine if you meet all the necessary requirements.

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 an advanced or metastatic (spread) solid cancer?
Has your doctor confirmed that your cancer has a KRAS mutation or amplification?
Are you able to attend regular clinic visits and undergo tests?
Have you discussed this trial with your doctor?

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 it's suitable for you. This will involve detailed medical history, physical exams, blood tests, and scans to assess your cancer.

You would then start taking the study drug, BGB-53038, which might be given on its own or with other treatments. The drug would likely be given regularly, either daily or on a specific schedule, and you would need to visit the clinic frequently for monitoring. These visits will include more blood tests, physical exams, and scans to check how you're responding to the drug and if you're experiencing any side effects.

The duration of your participation would depend on how your body responds to the treatment and whether it continues to be safe for you. You would be closely monitored throughout and after your treatment on the study.

Potential risks and benefits

Taking part in early-stage clinical trials like this can offer potential benefits, such as access to a new, promising medicine before it's widely available. Your cancer would also be closely monitored by a dedicated medical team. However, there are potential risks, as the drug is new and its full range of side effects isn't yet known. You might experience side effects that could be uncomfortable or even serious. It's also possible that the drug may not benefit your specific cancer. You have the right to withdraw from the study at any time, for any reason, without affecting your future 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 is a 'solid tumour'?

A solid tumour is an abnormal mass of tissue that doesn't contain cysts or liquid areas. Most cancers are solid tumours.

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it first started to other parts of the body.

What is a 'KRAS mutation or amplification'?

KRAS is a gene. A 'mutation' is a change in this gene, and 'amplification' means there are too many copies of it. Both can cause cancer to grow and spread.

Is this medicine available outside the study?

No, because this is an early-stage study, the medicine BGB-53038 is not currently available outside of this research trial.

What does 'Phase 1' mean for a study?

Phase 1 is the very first step in testing a new medicine in people. It mainly focuses on checking if the drug is safe and finding the right dose, rather than how well it treats the disease.