AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A Study Testing the Investigational Drug XmAb541 in people with Advanced Cancer

This research study is looking into a new medicine, XmAb541, for individuals who have advanced solid tumours. It's a very early stage of testing, called a Phase I trial, which means it’s the first time this medicine is being given to people. The main aim is to understand how XmAb541 behaves in the human body, to see if it's safe, and to find the right dose. Participants will be closely monitored by a medical team. This type of study is crucial for learning more about potential new treatments for cancer, though it’s important to remember that it's still very early in the development process.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Xencor Inc.

Enrolment target

Start

27 Oct 2025

Advanced Solid Tumors

What is this study about?

Imagine your body has tiny soldiers that fight off illness. For people with cancer, sometimes these soldiers need a little help. This study is testing a new medicine, called XmAb541, that scientists hope might give those soldiers a boost, or directly target cancer cells.

This is a very early step in testing new medicines, called a Phase I study. Think of it like taking a new car for its very first test drive. Doctors want to see how the medicine works in people for the first time, checking that it's safe and how the body handles it. They will also be looking for any early signs that it might be helping to treat advanced solid tumours.

Taking part in a study like this helps researchers learn a lot. Even if a medicine turns out not to be the right treatment, the information gained is incredibly valuable. It helps future research and brings us closer to finding better ways to fight cancer. Your involvement, if you choose to take part, could make a significant difference to medical knowledge.

Key takeaways

This study is testing a new cancer medicine called XmAb541.
It's a very early-stage study (Phase I) for advanced solid tumours.
The main goals are to check the medicine's safety and how it works in the body.
Anyone 18 or older with advanced solid tumours might be eligible.
You can stop participating at any time without affecting your care.

Who may be eligible?

To be part of this study, you would need to be an adult, aged 18 or older. There is no upper age limit. Both men and women can take part.

You would also need to have been diagnosed with advanced solid tumours. The doctors running the study will check other specific health details to make sure the study is a safe and suitable option for you. This will involve reviewing your medical history and doing some tests.

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?
Have you been diagnosed with advanced solid tumours?
Are you able to attend regular hospital or clinic visits?
Are you comfortable with receiving an investigational medicine?
Are you generally able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, XmAb541. This would involve regular visits to the hospital or clinic for tests, check-ups, and to receive your medication. During these visits, the study team would closely monitor your health by taking blood samples, doing scans, and asking how you are feeling. The frequency of these visits and tests might change over the course of the study.

The study team will explain everything in detail, including how you’ll receive the medicine, how long you might be taking it, and how long the follow-up period will last after you stop receiving the medication. You'll have a chance to ask any questions you have about the process.

Potential risks and benefits

While there's a chance the new medicine might help your condition, for some people, medicines in early stages of testing don't always show a direct benefit. There are also potential risks, such as side effects from the medicine, which could be mild or more serious. The medical team will carefully explain all known and potential risks before you decide to join. Remember, taking part in any study is entirely your choice, and you are free to withdraw at any time for any reason, without it affecting your usual medical care.

Locations (4)

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
France
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Unverified
Belgium
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Unverified
Denmark

Common questions

What does 'advanced solid tumours' mean?

This refers to cancers that have started in a solid organ (like the breast, lung, or bowel) and have spread or are difficult to treat with standard therapies.

What is a 'Phase I' study?

It's the very first stage of testing a new medicine in people. Doctors want to find out if it's safe, how much medicine the body can handle, and how it works.

Will I definitely get the new medicine?

Yes, in this type of study, all participants who meet the eligibility criteria will receive the investigational medicine XmAb541.

What if I feel unwell during the study?

The study team will monitor you closely. You should always tell them immediately if you feel unwell or notice any changes in your health. They are there to help.

How long does a study like this usually last?

The total length of time you would be involved, including follow-up, can vary a lot, but the study team will explain the expected duration for participants before you decide to join.