AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

A Multicenter, Open-label, Phase 1/2 Safety Run-in and Expansion Study of PM54 in Combination With Immunotherapy Evaluating Safety and Efficacy in Adult Participants who were Previously Treated for Advanced Malignancies

Doctors are studying a new medicine called PM54 together with a proven cancer treatment called pembrolizumab. This study is for adults who have advanced cancers that have been treated before. The main goals are to carefully check for any side effects from this new combination and to find the best and safest dose. We also want to understand if this treatment can shrink tumours, stop them from growing, or help people live longer. This research is important because it could lead to new ways to treat advanced cancers.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Pharma Mar S.A.

Enrolment target

Start

24 Apr 2026

Advanced malignancies

What is this study about?

This study is looking into a new way to treat advanced cancers. Advanced cancer means the cancer has spread from where it started to other parts of the body. Doctors are testing a new medicine called PM54 in combination with an immunotherapy drug called pembrolizumab. Pembrolizumab helps your body's own immune system fight cancer, and PM54 is designed to work with it. The study is split into two main parts. First, researchers will carefully give increasing doses of PM54 to a small group of patients to find the safest dose and monitor for any side effects.

Once the safest dose is found, more patients will join the second part of the study. Here, doctors will continue to look at safety, but also focus on how well the treatment works. This includes seeing if the treatment can shrink tumours or stop them from growing. They will also measure how long the treatment keeps the cancer under control and how it affects patients' overall health.

This research is important because advanced cancers can be challenging to treat. By exploring new combinations of medicines, doctors hope to find more effective treatments that can improve the lives of people living with these conditions. It's a careful step-by-step process to ensure new treatments are both safe and helpful.

Key takeaways

This study is for adults with advanced cancer that has been treated before.
It tests a new medicine (PM54) combined with an existing immunotherapy (pembrolizumab).
The main aims are to check for safety, find the right dose, and see if the treatment helps.
Participants will have regular check-ups, blood tests, and scans.
There's a chance the new treatment could help, but also a risk of side effects.
You can withdraw from the study at any time.

Who may be eligible?

This study is open to adult patients, meaning anyone aged 18 years or older, regardless of their gender. Participants will need to have a type of advanced cancer that has been treated before with other methods but is no longer responding well to those treatments.

Before joining, doctors will check your overall health and your specific cancer type to make sure the study is a good fit for you. There will be other specific health requirements and medical background checks to ensure your safety during the study. These checks are standard for all clinical trials.

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 a type of advanced cancer?
Has your cancer been treated with other methods before?
Are you able to attend regular clinic appointments and follow-up visits?
Are you generally well enough to take part in medical research?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given PM54 along with pembrolizumab. This will involve regular visits to the clinic to receive your medication and for doctors to closely monitor your health. These visits will include checks like blood tests, scans (such as CT or MRI), and physical examinations to see how you are responding to the treatment and to check for any side effects.

The study will continue for a period, and you will have follow-up appointments even after you stop receiving the treatments, to track your progress and long-term health. The total length of your participation will depend on how you respond to the treatment and the study's overall plan, but ongoing monitoring is a key part of ensuring safety and understanding the treatment's effects.

Potential risks and benefits

Taking part in this study could offer a potential benefit by giving you access to a new treatment combination that might help with your advanced cancer, especially if other treatments haven't worked well. However, like all medicines, these treatments may have side effects. Doctors will watch you very closely for any unwanted effects and will manage them as best they can. 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
Spain

Common questions

What is 'advanced cancer' in this study?

'Advanced cancer' means the cancer has spread beyond its original site to other parts of your body.

What is immunotherapy?

Immunotherapy is a type of treatment that helps your body's own immune system fight the cancer cells.

How often would I need to visit the clinic?

You would need regular visits, which will include receiving medication and having tests to check your health and how the treatment is working.

Will I know if the treatment is working?

Doctors will use scans and other tests to see if the treatment is shrinking your tumours or stopping them from growing, and they will discuss these results with you.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and it won't affect your future medical care.