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

A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors

This is a very early study, called a Phase 1 study, for men who have advanced prostate cancer that has spread to other parts of the body and is no longer responding to usual hormone treatments. The new drug, JNJ-70218902, is designed to help your body's immune system fight the cancer. Doctors want to check if the drug is safe, what the right dose might be, and how it behaves in your body. Because it's an early-stage study, it's the first time this specific drug is being given to people. This research is important for finding new ways to treat advanced prostate cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Janssen Cilag International

Enrolment target

Start

16 Sep 2024

Metastatic Castration-Resistant Prostate Cancer

What is this study about?

This study is looking at an experimental new medication called JNJ-70218902. It's being developed for men who have a type of prostate cancer that has spread (metastatic) and is no longer helped by hormone therapy, which is often called castration-resistant prostate cancer. This is a "Phase 1" study, which means it's one of the very first times this specific drug is being given to people. The main goals at this stage are usually to check if the drug is safe, to understand how it affects the body, and to find a dose that patients can tolerate.

The drug, JNJ-70218902, is a type of treatment that helps 'redirect' your body's immune cells, called T-cells, to target and fight cancer cells. Think of it like giving your immune system a special map to find and attack the cancer more effectively. Researchers hope that by boosting the immune system in this way, they can offer a new option for men battling this advanced form of prostate cancer.

Studies like this are a critical step in developing new medicines. They help scientists learn basic but important information about a new drug before it can be studied in larger groups of people. While it's still very early, this research contributes to the ongoing effort to find better treatments and improve the lives of those affected by prostate cancer.

Key takeaways

Tests a new immune-boosting drug for advanced prostate cancer.
It's a very early-stage (Phase 1) study, focusing on safety and dosage.
For men aged 18+ with advanced, hormone-resistant prostate cancer.
Aims to redirect the body's immune cells to fight cancer.
Participation involves regular clinic visits, tests, and medical monitoring.

Who may be eligible?

This study is specifically for men who are 18 years old or older. You must have advanced prostate cancer that has spread to other parts of your body. Importantly, your cancer should no longer be responding to hormone treatments, which doctors might call 'castration-resistant' prostate cancer.

To be considered, doctors will also check other things like your general health, how well your organs are working, and previous treatments you've had. These checks are to make sure that taking part in the study would be safe for you. It's important to remember that not everyone who meets the basic age and condition requirements will be able to join, as there are many detailed safety criteria involved.

Quick self-check

Are you a man aged 18 or older?
Do you have advanced prostate cancer that has spread?
Is your prostate cancer no longer responding to hormone treatments?
Are you able to travel to study appointments?
Are you willing to follow a strict study schedule?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive the investigational drug, JNJ-70218902. You would have several visits to the clinic for medical checks, blood tests, and scans to monitor your health and how the drug is affecting you and your cancer. You'll likely need to stay at the clinic for certain periods, especially at the beginning, so doctors can carefully watch for any effects of the drug.

The exact number of visits, tests, and the total length of time you'd be involved will depend on your individual response and the specific stage of the study you join. Clinical trial teams will explain this in detail. There will also be a follow-up period after you stop taking the study drug to ensure your health is still monitored.

Potential risks and benefits

As with any new medication, there are potential benefits and potential risks to consider. While there's no guarantee the experimental drug will help your cancer, you might benefit from close medical monitoring and access to a new treatment option not yet widely available. Potential risks commonly include side effects from the drug, which can range from mild to serious, and the exact nature of these are still being discovered in a Phase 1 study. It's important to know that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What does 'Phase 1 study' mean?

A Phase 1 study is a very early stage of research where a new drug is given to people for the first time. The main goals are to check if it's safe and to find the right dose.

What kind of cancer is this study for?

This study is for men with advanced prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone treatments.

What is JNJ-70218902?

It's a new experimental drug that aims to help your body's immune system fight the cancer.

Will this drug cure my cancer?

This is an early-stage study, and we can't say if it will cure cancer. The aim is to see if it's safe and how it works, and hopefully lead to better treatments.

Do I have to pay to join the study?

Clinical trials typically cover the costs of the study drug and specific study-related procedures. Travel and other expenses may or may not be covered; you should ask the study team.