Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM14 in Combination with Irinotecan in Pretreated Patients with Selected Advanced Solid Tumors

This research is looking into a new treatment, PM14, given with an established cancer drug, Irinotecan, for certain advanced solid cancers that have been treated before. It's a two-part study. First, researchers will carefully increase the dose of PM14 to find the highest safe dose that patients can take without too many side effects. This helps them decide on the best dose for future studies. In the second part, they will use this best dose to see how many patients respond to the treatment, meaning their tumours shrink or stop growing. They will also keep a close eye on any side effects and understand how the body processes the new medicine. The main goal is to find out if this combination therapy is a good and safe option.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pharma Mar S.A.

Enrolment target

Start

12 Aug 2024

Patients with Selected Advanced Solid Tumors

What is this study about?

This study is a clinical trial, which means it's a carefully planned way to test new treatments to see if they are safe and effective. In this particular study, doctors are looking at a new medicine called PM14, which will be given together with a standard cancer drug called Irinotecan. This combined treatment is for people who have certain types of advanced solid cancers that have already been treated with other medicines.

The study has two main stages. The first stage is like a cautious exploration. The doctors will start with a very low dose of PM14 and gradually increase it in different groups of patients. Their main aim here is to find the highest dose they can give without causing too many uncomfortable side effects. This safe and effective dose is then used in the second stage of the study.

In the second stage, doctors will use the best dose they found to see how well the treatment works. They will be looking at how many patients have their tumours shrink or stop growing. They will also continue to monitor any side effects and collect information about how the body uses and gets rid of the drugs. This helps them understand if PM14 with Irinotecan could be a helpful new treatment option for people with advanced solid cancers.

Key takeaways

Tests a new drug (PM14) with an existing cancer drug (Irinotecan).
Aims to find the safest and best dose of PM14.
For specific advanced solid cancers previously treated.
Carefully monitors side effects and tumour response.
You'll get the combined treatment if you join.

Who may be eligible?

To be able to join this study, participants need to be at least 18 years old. This study is open to both men and women.

Before joining, doctors will carefully check your medical history, including any previous cancer treatments you've had. They will also do tests to make sure you are healthy enough to take part and that the study treatment would be suitable for your specific type of advanced solid tumour.

There will be other specific rules about your health and your cancer that doctors will need to check to make sure you can safely and effectively participate in the trial.

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 at least 18 years old?
Do you have an advanced solid cancer diagnosis?
Have you had previous treatments for your cancer?
Are you able to attend regular hospital or clinic appointments?
Are you willing to have blood tests and scans as part of the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive doses of PM14 and Irinotecan. The exact schedule will be explained by the study team, but you can expect regular visits to the hospital or clinic for your treatment and check-ups. During these visits, doctors and nurses will monitor your health, take blood and urine samples, and possibly perform scans to see how your cancer is responding to the treatment.

They will also ask you how you are feeling and if you are experiencing any side effects. You might need to fill out questionnaires. The study team will explain how long you will receive treatment and how often you will have follow-up appointments after your treatment finishes. All these steps are important to collect the necessary information about the new treatment.

Potential risks and benefits

Participating in a clinical trial offers the chance to access a new treatment before it's widely available. While there's no guarantee the treatment will work for you, your health will be carefully monitored throughout the study. However, like all medicines, PM14 and Irinotecan can have side effects, which could range from mild to more serious. The study team will explain all known or potential risks to you before you decide to join. Remember, you can choose 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 kind of cancer is this study for?

This study is for people with certain types of advanced solid cancers that have already been treated with other medicines.

What are PM14 and Irinotecan?

Irinotecan is an existing cancer drug. PM14 is a new medicine being tested alongside Irinotecan in this study.

What does 'dose escalation' mean?

It means the study will start with a low dose of PM14 and gradually increase it in different groups of patients to find the safest and most effective amount to give.

Will I definitely get the new drug?

Yes, if you join this study, you will receive PM14 in combination with Irinotecan. There is no placebo group in this trial.

What are the main goals of the study?

The main goals are to find the best dose of PM14, see how many patients respond to the treatment, and understand how the body handles the new medicine.