Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1 Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors

This study is looking into a new medicine known as JNJ-79032421. It's designed for people who have advanced solid tumours, which are cancers that have spread. This is a very early-stage trial, meaning it's one of the first times this medicine is being given to people. The main goal is to check its safety and how the body handles it. Researchers also want to see if it has any effect on a protein called mesothelin, which is often found on cancer cells. Taking part would help scientists learn more about this potential new treatment, although it's important to remember that it's still in the very early stages of development.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Janssen - Cilag International

Enrolment target

Start

09 Jan 2024

Advanced Stage Solid Tumors

What is this study about?

This study is about a new medicine called JNJ-79032421 that is being developed to treat advanced solid tumours. Solid tumours are cancers that form a lump, like those found in the breast, lung, or bowel. When we say 'advanced', it means the cancer may have spread to other parts of the body.

This particular study is a 'Phase I' trial. This means it's one of the very first times this new medicine is being given to people. The main aim at this stage isn't to cure cancer, but to carefully check if the medicine is safe and to understand how the body reacts to it, including what dose might be best. Researchers will be looking to see if it has any effect on a specific protein called mesothelin, which is often found on the surface of some cancer cells.

Taking part in such an early study is a way for people to potentially access new treatments that aren't yet widely available. It also helps doctors and scientists gather vital information that could lead to new treatments for future patients. While it's understandable to hope for benefits, it's really important to remember that the main goal right now is safety and understanding the drug, and there's no guarantee the treatment will directly help your cancer.

Key takeaways

This is a very early study of a new medicine for advanced solid tumours.
The main aim is to check the medicine's safety and how it works in the body.
It targets a specific protein called mesothelin, found on some cancer cells.
Participants must be 18 or older and have advanced solid tumours.
Taking part means regular clinic visits for treatment and health checks.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There's no upper age limit, meaning older adults are also welcome to take part if they meet other health requirements.

This study is for people who have been diagnosed with advanced solid tumours. The research team will need to check your medical history to make sure the study medicine is suitable for you. They will also look at your overall health to ensure it's safe for you to take part.

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 generally well enough to take part in a study?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have a screening visit first. This is to ensure you meet all the health requirements. Then, you would receive the study medicine, probably through an injection or infusion, at regular intervals. You'd have several visits to the clinic for medical check-ups, blood tests, and other assessments to see how you're responding to the treatment and to monitor for any side effects. These visits might be frequent initially and then become less often over time. After you stop receiving the medicine, there would probably be follow-up appointments to keep an eye on your health. The total time you'd be involved in the study would depend on how your treatment proceeds and the study's design.

Potential risks and benefits

Participating in any clinical trial involves both potential benefits and risks. There's a possibility you could benefit from this new medicine, though because it's a very early-stage trial, the main goal is to find out if it's safe rather than directly treating your cancer. There's also a risk of side effects from the medicine, some of which might be serious, and others might not be known yet. The study team will explain all the known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 does 'advanced solid tumours' mean?

This refers to cancers that have started in a solid organ (like the lung or breast) and have either spread or are difficult to treat with standard therapies.

What is a 'Phase I' study?

It's the first stage of testing a new medicine in people. The main goals are to check if it's safe, find the right dose, and see how the body handles it.

What is 'mesothelin'?

Mesothelin is a protein that can be found in high amounts on the surface of some cancer cells. This new medicine is designed to target it.

Will this medicine cure my cancer?

In a Phase I study, the primary focus is on safety, not on curing the cancer. While some people might see their cancer respond, it's not the main goal, and there are no guarantees.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, for any reason. Your decision won't affect your future medical care.