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

Phase I study of MGY825 in patients with lung cancer

This is an early-stage research study, often called a Phase 1 trial, looking into a new medicine named MGY825. It's designed for adult patients who have advanced non-small cell lung cancer, which is the most common type of lung cancer. This study is the first time MGY825 will be given to people. The main goals are to find out if the medicine is safe, understand any side effects it might cause, and see how the body uses and gets rid of it. Researchers are particularly interested in patients whose cancer has specific genetic changes (called NFE2L2, KEAP1, or CUL3 mutations), but patients without these changes can also take part. This research is a crucial first step in developing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novartis Pharma AG

Enrolment target

Start

12 Dec 2023

Advanced non-small cell lung cancer with or without NFE2L2/KEAP1/CUL3 mutations in adult patients

What is this study about?

This study is a Phase 1 trial, which means it’s one of the first times a new medicine, called MGY825, is being tested in people. Think of it like taking the very first steps with a new idea. It’s a really important stage in developing new treatments, as it helps doctors understand if a new medicine is safe enough to study further and how the human body reacts to it.

The main aim of this particular study is to learn more about MGY825 in adults who have advanced non-small cell lung cancer. This is the most common type of lung cancer. Researchers want to find out the best dose to give people, look for any side effects, and see how the medicine acts in the body. They’re also looking at whether the medicine might work differently in people whose cancer has specific genetic changes, though it’s open to people with or without these changes.

Finding new ways to treat cancer is a long and careful process. Studies like this one are vital because they lay the groundwork for potential future treatments. Even though it's an early stage, every step helps us understand more about cancer and how to fight it.

Key takeaways

This is an early-stage study testing a new drug (MGY825) for lung cancer.
It's for adults with advanced non-small cell lung cancer.
The main goal is to check for safety and how the body handles the medicine.
Participation includes regular clinic visits and health checks.
You have the right to stop participating at any time.
This study is crucial for developing potential future cancer treatments.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. The study is open to both men and women.

You should have a type of cancer called advanced non-small cell lung cancer. This means your cancer has spread beyond its original location or has returned after previous treatments.

The study is looking for people whose cancer either has specific changes in certain genes (called NFE2L2, KEAP1, or CUL3 mutations) or whose cancer does not have these changes. This means many people with advanced non-small cell lung cancer might be suitable.

Quick self-check

Are you 18 years old or older?
Do you have advanced non-small cell lung cancer?
Are you able to attend regular hospital or clinic visits?
Are you comfortable potentially trying a new medicine for the first time in people?

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 have regular visits to the hospital or clinic. These visits would involve check-ups, blood tests, and other medical assessments to see how you are responding to the new medicine, MGY825, and to monitor your health. You would be given the study medicine as directed by the research team. The exact number of visits, tests, and the total length of your participation would depend on the study's plan and your individual response, but this will be fully explained to you before you agree to take part. There will also be a period of follow-up after your treatment ends to ensure your well-being.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. You might not directly benefit from this early-stage study, as its main purpose is to learn about the new medicine's safety, but the information gained could help others in the future. There is a chance of experiencing side effects from the new medicine, which the study team will carefully monitor and manage. You would be fully informed of all known potential risks before deciding to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

—
Germany
—
Spain

Common questions

What is a Phase 1 study?

A Phase 1 study is the first time a new medicine is tested in a small group of people. It focuses on safety and finding the right dose.

What type of cancer is this study for?

This study is for adults with advanced non-small cell lung cancer.

What is MGY825?

MGY825 is a new medicine that is being investigated for the first time in humans in this study.

Do I need to have a special genetic change to join?

No, you don't necessarily need a special genetic change in your cancer. People with or without certain genetic changes can take part.

Will I get better if I join this study?

While the aim is to find new treatments, there's no guarantee you will personally get better from this early-stage study. Its main goal is to gather safety information.