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

A phase I study of [177Lu]Lu-EVS459 in patients with ovarian and lung cancers

This early-stage research is looking into a new medicine called [177Lu]Lu-EVS459. It's designed for people with advanced ovarian cancer (a type called high-grade serous) and certain types of advanced lung cancer (non-small cell lung carcinoma). This particular study is the very first time this medicine will be given to human patients. The main goals are to see if it's safe, how much of it the body can handle, and how it moves through and is processed by the body. This kind of research is essential for understanding if a new treatment has the potential to help patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novartis Pharma AG

Enrolment target

Start

05 Nov 2024

Advanced high-grade serous ovarian cancer (OC)Locally advanced unresectable or metastatic non-squamous non-small cell lung carcinoma (NSCLC)

What is this study about?

This study is a very early step in testing a new treatment called [177Lu]Lu-EVS459. Researchers want to see how this new medicine works in people for the first time. They are focusing on two specific types of cancer: advanced ovarian cancer (where the cancer has spread or come back) and a kind of lung cancer that can't be removed by surgery or has spread to other parts of the body.

The main purpose of this study is to find out if the new medicine is safe and what dose can be given without causing too many side effects. It will also look at how the medicine travels through the body and how long it stays there. This information is really important because it helps scientists decide if the treatment has a good chance of being helpful for patients in larger studies later on.

Because this is the first time the medicine is being used in people, the study will involve a small number of patients. The results from this early research will help doctors understand more about [177Lu]Lu-EVS459 and its potential to fight cancer in the future. It's a crucial step in developing new therapies.

Key takeaways

This is an early-stage study (Phase I) of a new cancer medicine.
It's for specific types of advanced ovarian and lung cancers.
The main aim is to check the new medicine's safety and how it works in the body for the first time in humans.
It's not guaranteed to help your cancer, as it's exploratory research.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women are welcome to take part. The study is specifically for individuals who have advanced high-grade serous ovarian cancer or a type of advanced lung cancer called non-small cell lung carcinoma that cannot be treated with surgery or has spread.

There will be other specific health requirements that your doctors will check to make sure the study is right and safe for you. These might include certain blood test results, how well your organs are working, and if you have other health conditions that could affect the study or your safety. Your medical team will carefully review your health history to see if you meet all the criteria.

It's important to remember that joining a clinical study is a big decision, and not everyone will be suitable. Even if you have one of the cancers mentioned, other health factors might mean this particular study isn't the best option for you. Your doctor will discuss all of this with you 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 high-grade serous ovarian cancer?
OR do you have advanced non-small cell lung cancer that cannot be surgically removed or has spread?
Are you able to attend regular hospital visits for assessments and treatment?
Are you willing to follow all study instructions and procedures?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve regular visits to the hospital or clinic. During these visits, you’d have various tests, such as blood tests, scans, and possibly other examinations to monitor your health and how the treatment is affecting you. You would receive the study medicine, [177Lu]Lu-EVS459, according to a specific schedule decided by the research team.

The research team will closely watch you for any side effects and to see how your body is responding to the treatment. The total duration of your participation and the number of visits would be explained fully by the study team, as it can vary depending on your individual response and the study's design. There will also be follow-up appointments after you stop receiving the treatment to continue monitoring your health and any effects.

Potential risks and benefits

Taking part in any clinical study carries potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that isn't yet widely available, which could potentially help your condition, though this is not guaranteed, especially in early-stage studies. However, the medicine may cause side effects, some of which could be serious or unexpected, as it's the first time it’s being given to people. The study team will explain all known and potential risks before you decide to join. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Netherlands
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Unverified
Germany
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Unverified
France
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Unverified
Italy

Common questions

What kind of study is this?

This is a 'Phase I' study, which means it's the very first time this new medicine is being tested in people. Its main goal is to check safety and how it works in the body.

What cancers is this study for?

It's for people with advanced high-grade serous ovarian cancer or specific types of advanced lung cancer that cannot be removed by surgery or have spread.

What is [177Lu]Lu-EVS459?

It's the name of the new medicine being tested. It's an experimental treatment, meaning it's not yet approved for public use.

Will I definitely get better if I join?

No, there's no guarantee that participating will make you feel better or cure your cancer, especially in these early-stage studies. The main purpose is to learn about the new medicine.

Who can join this study?

Adults aged 18 and over, both men and women, who have one of the specific advanced cancers mentioned. Your doctors will check other health details to see if you're suitable.