Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients with Advanced Solid Tumors

This study is about a new medicine called PM14 for people with advanced solid tumours, which are cancers that have grown or spread. This is an early-stage study, meaning it's one of the first times this medicine is being given to people. The main goals are to find a safe and effective dose of PM14 and to understand how the body handles it. Participants will receive the medicine through a drip (intravenously). Doctors will carefully watch how the medicine affects the cancer and check for any side effects. Advanced solid tumours include many different types of cancer, not limited to one specific kind. This research helps us learn more about new potential treatments.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Pharma Mar S.A.

Enrolment target

115

Start

26 Apr 2024

Advanced Solid Tumors

What is this study about?

This study is an early step in testing a new medicine called PM14 for people with advanced solid tumours. "Advanced solid tumours" means cancers that have grown or spread from where they started. This study is called a 'Phase I' study, which means it's one of the very first times this experimental medicine is being given to humans. Researchers need to test it thoroughly before it can be used more widely.

The main purpose of this study is to find the best, safest dose of PM14. They will start with a small dose and gradually increase it, watching participants very carefully for any effects, good or bad. They also want to understand how the medicine moves through and is used by the body – this is called pharmacokinetics. Knowing this helps them figure out the best way to give the medicine.

Participants in this study will receive the PM14 medicine through a drip into a vein. Doctors will regularly check how your body is responding to the medicine, both in terms of side effects and any changes to the cancer. This kind of research is really important because it helps scientists learn if new treatments like PM14 could eventually help people battling cancer.

Key takeaways

This is an early study of a new cancer medicine called PM14.
It's for adults with various types of 'advanced solid tumours'.
The main aims are to find a safe dose and understand how the medicine works.
The medicine is given through a drip into a vein.
Participation involves regular hospital visits for tests and treatment.
You can stop taking part at any time without penalty.

Who may be eligible?

This study is for adults generally aged 18 years and older who have been diagnosed with advanced solid tumours. This means your cancer has either spread or is no longer responding to standard treatments. Both men and women can take part in this research.

To be considered for this study, you would need to meet certain health requirements. For example, your doctors will check your overall health and make sure your organs (like your liver and kidneys) are working well enough for you to safely receive the new medicine.

It's important to remember that joining a clinical study has strict rules. These rules are there to keep you safe and to make sure the study results are clear. Your regular doctor and the study team would need to confirm if this specific study is right for you, based on all your health information.

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 an advanced solid tumour?
Are you able to attend regular hospital appointments?
Are you generally well enough to try a new treatment?
Have standard treatments for your cancer been tried or are no longer working for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital or clinic. These visits will involve blood tests to check how the medicine is affecting your body and how your body is handling the medicine. You might also have scans or other tests to see how your cancer is responding.

The new medicine, PM14, will be given to you through a drip into a vein. The doctors and nurses will monitor you closely during and after you receive the medicine. The study will continue for a certain period, and you will have follow-up visits even after you stop taking the medicine to make sure you are doing well. The full duration of your participation, including follow-up, will be clearly explained by the study team.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as access to a new treatment before it's widely available. Early studies like this are crucial for developing future cancer therapies. However, there are also potential risks; as this is a new medicine, not all side effects are known, and some could be serious. The medicine might not work for everyone, or it might not work at all. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

Common questions

What does 'advanced solid tumours' mean?

This refers to cancers that started in a solid organ (not blood cancers) and have either grown significantly or spread to other parts of the body.

What is a 'Phase I' study?

It's the very first stage where a new medicine is tested in humans. The main goal is to find a safe dose and see how the body reacts to it.

How will I receive the medicine?

The medicine, PM14, will be given to you through a drip (intravenously) into a vein.

Will I get better if I join this study?

This study aims to find a safe dose and see how the medicine works, but there's no guarantee the medicine will improve your condition. Its effectiveness is what researchers are trying to discover.

Can I stop participating if I want to?

Yes, you are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.