Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A MULTICENTER, SINGLE-ARM, THREE COHORT, PHASE II TRIAL OF PATRITUMAB DERUXTECAN (HER3-DXD) IN PATIENTS WITH ACTIVE BRAIN METASTASES FROM HER3-EXPRESSING ADVANCED BREAST CANCER AND NON–SMALL CELL LUNG CANCER, AND IN PATIENTS WITH LEPTOMENINGEAL CARCINOMATOSIS FROM HER3-EXPRESSING ADVANCED SOLID TUMORS (The TUXEDO-3 Study)

This research study, called TUXEDO-3, is testing a new treatment named Patritumab deruxtecan. It's for people with advanced breast cancer or non-small cell lung cancer that has spread to the brain, or for those with certain advanced solid cancers where the cancer has spread to the lining of the brain and spinal cord (leptomeningeal carcinomatosis). The main goal is to see how effectively this new drug shrinks tumors and to understand if it helps people live longer. This is a Phase II study, meaning it's exploring how well the treatment works and ensuring it's safe, after earlier tests have shown promise. Researchers will be carefully monitoring participants to understand the drug's effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medica Scientia Innovation Research S.L.

Enrolment target

Start

10 Oct 2023

Metastatic Breast Cancer or Advanced Non-Small Cell Lung Cancer with asymptomatic untreated or progressing Brain Metastases or solid tumors with Leptomeningeal disease

What is this study about?

This study is investigating a new medication called Patritumab deruxtecan for specific types of advanced cancer. The main focus is on advanced breast cancer and advanced non-small cell lung cancer that has spread to the brain. It also includes people with other advanced solid cancers where the cancer has spread to the delicate membranes protecting the brain and spinal cord, a condition known as leptomeningeal carcinomatosis.

The research aims to find out how effective this new drug is at reducing the size of the tumors, both in the brain and in other parts of the body. For some patients, the study will also look at how many people are still alive three months after starting the treatment. By understanding these effects, doctors hope to gain valuable information about whether Patritumab deruxtecan could be a helpful treatment option for these challenging cancers.

This is a Phase II study, which means it's an important step in developing new treatments. Drugs typically go through several phases of testing. Phase I studies check for safety, and Phase II studies like this one explore how well the treatment works and continue to monitor for side effects. If the results are promising, the drug might move on to larger Phase III studies, where it would be compared to existing treatments.

Key takeaways

Tests a new drug called Patritumab deruxtecan.
Aims to treat advanced breast/lung cancer spread to the brain, or other solid cancers spread to the brain lining.
Main goals are tumor shrinkage and life expectancy for specific patient groups.
This is a Phase II study, exploring effectiveness and safety.
Participation involves receiving the drug and regular health check-ups.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. The study is open to both men and women.

Specifically, you would need to have advanced breast cancer or non-small cell lung cancer that has spread to your brain. This spread to the brain should either be new and untreated, or it might be cancer that has grown despite previous treatment. Alternatively, you might be eligible if you have another type of advanced solid cancer that has spread to the lining of your brain and spinal cord.

It's important to remember that these are just a few of the main criteria. Your doctor or the study team will review all your medical information to see if this study is the right fit for you, as there are many other detailed requirements for joining.

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 advanced breast cancer that has spread to your brain, or advanced non-small cell lung cancer that has spread to your brain?
Or, do you have another advanced solid cancer that has spread to the lining of your brain and spinal cord?
Has your brain cancer either not been treated yet, or has it grown despite previous treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study drug, Patritumab deruxtecan. You'll have regular hospital visits for treatments, health check-ups, and tests to monitor your progress and look for any side effects. These tests may include scans (like MRI or CT scans) to see how your tumours are responding, and blood tests to check your general health. The exact schedule for visits and tests will be explained in detail by the study team. You will continue to be monitored for a certain period even after you stop receiving the treatment.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and the chance to contribute to medical knowledge that could help others. However, there are also potential risks, as new treatments can have side effects that are not fully known. While this drug has been tested in earlier phases, some side effects might still emerge. The study team will explain all known risks and carefully monitor you throughout the trial. Remember, 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
Austria
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Unverified
Spain

Common questions

What is the main purpose of this study?

The main purpose is to see how well a new drug, Patritumab deruxtecan, works at shrinking cancer that has spread to the brain or brain lining, and to see if it helps people live longer.

What kind of cancer does this study focus on?

It focuses on advanced breast cancer or non-small cell lung cancer that has spread to the brain, or other advanced solid cancers spread to the brain and spinal cord lining.

What does a 'Phase II' study mean?

Phase II means researchers are trying to understand how effective the new treatment is and continue to look for side effects, building on safety information from earlier tests.

Will I get a new drug if I join?

Yes, if you join this study, you will receive the experimental drug called Patritumab deruxtecan.

Can I leave the study if I change my mind?

Yes, very importantly, you can decide to stop participating in the study at any time, for any reason, and your regular medical care will not be affected.