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

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of BG-60366 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer

This is an early research study, often called a Phase 1 study, for a new medicine named BG-60366. It's designed for adults who have a specific kind of lung cancer called EGFR-mutant non-small cell lung cancer. In this study, doctors are mainly trying to find out if the new medicine is safe for people and what the best dose might be. They also want to understand how the medicine moves through the body and how it might affect the cancer. Studies like this are a crucial first step in developing new treatments, helping scientists learn more about how a new medicine works before it can be tested in more people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

BeOne Medicines AG

Enrolment target

Start

12 May 2025

EGFR-Mutant Non-Small Cell Lung Cancer

What is this study about?

This research is looking into a brand-new medicine, called BG-60366, for people who have a specific type of lung cancer. This cancer is known as EGFR-mutant non-small cell lung cancer. The 'EGFR-mutant' part means there's a particular change in the cancer cells that might make them respond to certain medicines differently.

This study is in its very first stages of testing in humans, often called Phase 1. In this phase, the main goals are to make sure the new medicine is safe and to find the right dose. Researchers also want to learn how the medicine behaves in the body – for example, how long it stays in the system and if it has any effect on the cancer. It's a bit like giving a new recipe a test run to see if it's tasty and if everyone can eat it safely.

The information gathered in studies like this is really important. It helps scientists decide if the medicine is promising enough to continue testing in larger groups of people. This step-by-step process is how all new medicines are developed and approved, ensuring they are as safe and effective as possible.

Key takeaways

This is an early study of a new medicine for EGFR-mutant non-small cell lung cancer.
The main goals are to check the medicine's safety and find the best dose.
It's open to adults aged 18 and over.
You would receive a new, unproven medicine and undergo regular health checks.
Participation contributes to medical research and could offer potential benefits, but also involves unknown risks.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you would need to be 18 years old or older. The study is open to both men and women. The most important requirement is that you have been diagnosed with EGFR-mutant non-small cell lung cancer.

While the original description doesn't give many details, typically, other factors are considered. For example, doctors would likely look at your overall health, any other medical conditions you might have, and previous treatments you've received. This ensures the study is safe for you and that the results are clear.

Quick self-check

Are you 18 years old or older?
Do you have EGFR-mutant non-small cell lung cancer?
Are you able to attend regular appointments for tests and check-ups?
Are you willing to consider taking a new, experimental medicine?
Are you happy to discuss the study with your current doctor?

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 would be among the first people to receive this new medicine. You would have regular visits to the hospital or clinic for various tests. These tests might include blood samples, physical exams, and scans (like CT scans) to check how you are doing and how the medicine is affecting your body and the cancer. You would take the study medicine as directed by the research team.

The study would involve regular follow-up appointments, even after you stop taking the medicine, to continue monitoring your health. The total time you would be involved in the study could vary, depending on how you respond to the treatment and the study's design. The medical team will explain everything to you in detail.

Potential risks and benefits

Participating in an early-stage study like this means there's a chance you could benefit from a new medicine that isn't yet widely available, and you would be helping others by contributing to medical research. However, because it's a new medicine, there might be side effects that are not yet fully known or understood. The medical team will closely monitor you for any problems. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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Germany
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Italy
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Spain

Common questions

What does 'EGFR-mutant' mean?

It means your lung cancer cells have a specific change in their genes that doctors can identify. This change can sometimes make the cancer respond to particular treatments.

What is a 'Phase 1' study?

It's the very first time a new medicine is given to people. The main goals are to check if it's safe and to find the right dose.

Will this medicine cure my cancer?

It's too early to say. The main aim of this study is to check safety and find the right dose. While some people might see their cancer respond, this isn't guaranteed, and the medicine is still in early development.

Are there other treatment options for my condition?

Yes, there are usually standard treatments available for EGFR-mutant non-small cell lung cancer. Your doctor can discuss all your options with you.

How long would I be in the study?

The exact duration can vary, depending on how you respond and the study's plan. The research team will give you more specific details.