AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A phase I study of [68Ga]Ga-DWJ155 in patients with advanced breast and NSCLC cancers

This is a very early study looking at a new type of body scan called [68Ga]Ga-DWJ155. It's designed for people who have advanced breast cancer or a type of advanced lung cancer called non-small cell lung cancer (NSCLC). This is the very first time this particular scan is being tested in humans. The main goals are to make sure it's safe for people and to understand how it behaves in the body. Researchers are carefully observing any effects and how the scan might help them see cancer more clearly. This type of research helps doctors decide if a new imaging method is promising enough to be studied further.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novartis Pharma AG

Enrolment target

Start

03 Jul 2025

Advanced breast cancer and advanced NSCLC

What is this study about?

Imagine doctors want to get a clearer picture inside your body to understand your cancer better. This study is testing a brand-new way to do that, using something called [68Ga]Ga-DWJ155. Think of it like a special dye that doctors hope might highlight cancer cells when they do a scan.

This is a 'Phase I' study, which is the very first step when new treatments or tests are given to people. Because it's so new, the main things doctors want to find out are if it's safe to use and how your body reacts to it. They're not looking to treat your cancer in this study, but rather to understand if this new scan method has the potential to be helpful in the future.

The study involves people with advanced breast cancer or advanced non-small cell lung cancer (a common type of lung cancer). By participating, you would be helping doctors learn important information that could lead to better ways of understanding and managing these cancers in the future. It's a crucial step in medical research.

Key takeaways

This is an early-stage study testing a new type of cancer scan.
It's for people with advanced breast or non-small cell lung cancer.
The main goals are to check safety and how the special scan works in the body.
It's not a treatment for cancer, but aims to improve future cancer understanding.
You would receive a special injection and undergo scans.
Your participation helps advance medical knowledge for these cancers.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. There's no upper age limit, so older adults can also take part. The study is open to both men and women.

The most important health requirement is that you must have a diagnosis of advanced breast cancer or advanced non-small cell lung cancer. This means your cancer has spread or is difficult to treat with standard methods.

There will be other health checks and requirements you'll need to meet to make sure the study is safe for you. The study team will explain these in detail.

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 advanced breast cancer or advanced non-small cell lung cancer?
Are you able to attend study appointments as required?
Are you willing to undergo specific scans and procedures like injections?

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 full medical check-up to make sure it's suitable for you. This would involve things like blood tests and checking your general health. If you qualify, you would receive the special imaging agent, [68Ga]Ga-DWJ155, likely through an injection, followed by one or more scans. The number of visits, specific tests, and total time you'd be involved would be clearly explained by the study team. You would also have follow-up appointments to ensure everything is okay after the scan.

Potential risks and benefits

Because this is a very early study, the main 'benefit' is contributing to medical knowledge that could help future patients. There's no direct treatment for your cancer involved. Potential risks might include discomfort from injections, temporary side effects from the imaging agent itself, or minor risks associated with scans. All possible risks will be fully explained by the study team. 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
Netherlands

Common questions

What does 'Phase I' mean?

Phase I is the very first stage where a new medicine or type of scan is tested in people. The main goal is to check its safety and see how the body handles it.

Will this study treat my cancer?

No, this study is not designed to treat your cancer. It's about testing a new imaging method to gather information, not to cure or halt your disease.

What is 'advanced' cancer?

Advanced cancer usually means the cancer has spread from where it started to other parts of the body, or it's a type that's harder to treat locally.

What is [68Ga]Ga-DWJ155?

It's a new tracer, like a special dye, that doctors hope will help them see cancer cells more clearly using a type of scan. It's still in very early testing.

How long would I be in the study?

The exact length of your participation, including visits and follow-ups, would be fully explained by the study team before you decide to join. It's typically for a shorter period in Phase I studies.