RecruitingPhase IInterventional

Phase I study of PM534 to patients with advanced solid tumors

This is a very early study, called a Phase I trial, looking into a new medicine known as PM534. It's for people who have advanced solid tumors, which are cancers that form a lump. The main goal of this type of study is to check if the new medicine is safe and to find the right dose. At this moment, many of the specific details about the trial, such as what treatments are involved and who can join, are not yet fully available. This is because the Health Research Authority, which checks that research is ethical and safe, has given the researchers more time to provide all the information. These missing details will be added to the trial record very soon. The study is open to both men and women between the ages of 18 and 100.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

PharmaMar (Spain)

Enrolment target

Start

10 Apr 2026

Estimated completion

30 Jul 2027

The Health Research Authority has approved a deferral. Full details will be added to the trial record on or before the deferral expiry date.

What is this study about?

This study is a Phase I trial, which is the very first step in testing a new medicine in people. The medicine is called PM534 and it's being explored for its potential use in people who have advanced solid tumors. Advanced solid tumors are cancers that have grown or spread in the body.

In Phase I studies like this one, the main things researchers want to find out are whether the new medicine is safe for people to take and what dose works best without causing too many side effects. They also start to look at how the medicine works in the body. It’s important to remember that because this is such an early stage, we don't know yet if PM534 will be an effective treatment for cancer.

Currently, some of the detailed information about this study, such as exactly how the medicine will be given, what tests will be done, and the full list of who can and cannot join, is not yet public. This is because the Health Research Authority (HRA), which makes sure all research in the UK is ethical and proper, has given the research team a bit more time to finalise and share all these specifics. This full information will be made available very soon, likely before a certain date they have set.

Key takeaways

This is a Phase I study, the earliest stage of testing a new medicine.
The study is for people with advanced solid tumors.
It aims to find out if the new medicine, PM534, is safe and what dose to use.
More detailed information about the study is coming soon.
Adults aged 18-100, both male and female, can potentially take part.

Who may be eligible?

At the moment, the full details about who can and cannot join this study are not completely available. This information will be added to the study's record very soon.

However, we do know that the study is open to adults across a wide age range, specifically those aged between 18 and 100 years old. Both men and women are welcome to take part.

When the complete details are released, they will explain important things like what kind of cancer you need to have, any other health conditions that might prevent you from joining, and other tests or treatments you might have had previously.

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?
Are you 100 years old or younger?
Do you have a solid tumor that is advanced?
Are you a man or a woman?

Answer every question to see your result.

What does participation involve?

Because the full study details are not yet completely public, we don't have all the specifics about what taking part will involve. However, typically in a Phase I study:

* **Visits:** You would likely have regular visits to the hospital or clinic for check-ups, blood tests, and to receive the study medicine. * **Assessments:** These visits would include various tests to monitor your health, how your body is reacting to the medicine, and potentially scans to check your cancer. * **Medication:** You would receive the study drug, PM534, likely in a set way (e.g., as a pill or through a drip) at specific times. * **Follow-up:** After you finish taking the medicine, you would continue to have follow-up appointments to monitor your health and any long-term effects. * **Total Duration:** The total time you would be involved in the study could range from several months to potentially longer, depending on how often the treatment is given and how long follow-up is needed.

Once the full details are released by the Health Research Authority, they will provide a clear schedule of what is expected.

Potential risks and benefits

As this is a very early-stage study, any potential benefits are not yet known. The main aim is to check the medicine's safety and find the right dose. While there's a chance the medicine might help your condition, it's also possible it won't have any effect, or could cause side effects. All possible risks, even serious ones, will be carefully explained once the full details are released. You would also be told about your right to leave 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.

University College London Hospitals NHS Foundation Trust
Unverified
London, England

Common questions

What is a Phase I study?

A Phase I study is the very first time a new medicine is tested in people. The main goals are to check if it's safe and to find the best dose.

What kind of cancer is this study for?

This study is for people with advanced solid tumors, which are cancers that form a lump and have grown or spread.

Can women join this study?

Yes, both women and men are welcome to take part in this study.

When will more details about the study be available?

The full details about the study will be added to the trial record very soon, as the Health Research Authority has given more time to provide information.

What does PM534 mean?

PM534 is the name given to the new medicine being tested in this study.

How to find out more

Pharma Mar S.A. Clinical Development Oncology Unit

clinicaltrials@pharmamar.com 34918466000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.