RecruitingPHASE1INTERVENTIONAL

A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer

This research study is looking into a new combination of two drugs, Pasritamig and JNJ-86974680, for men living with advanced prostate cancer. Initially, the study aims to find the most suitable and safest dose of these two drugs when given together. Once this dose is found, the study will then look at how well people tolerate this combined treatment and its effects on their cancer. This is a very early-stage study, meaning it's one of the first times these drugs are being tested in people. The hope is to find a new way to treat prostate cancer, providing more options for patients in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Janssen Research & Development, LLC

Enrolment target

Start

14 Jan 2026

Estimated completion

30 Apr 2027

Prostatic Neoplasms

What is this study about?

Imagine your doctor telling you about a new approach to treating prostate cancer. That's what this study is exploring. Researchers are carefully testing two new medications, Pasritamig and JNJ-86974680, to see how they work together to fight advanced prostate cancer. Think of it like trying a new recipe – you first need to figure out the right amounts of each ingredient to make it taste best and be safe to eat. Similarly, this study's first step is to find the best and safest dose of these two drugs when used in combination.

After they've found this 'recommended' dose, the study will then involve more people with advanced prostate cancer. The aim here is to see how well patients tolerate this specific dose and how it affects their cancer over time. This is an important step in developing new treatments because it helps doctors understand if the drugs are safe and if they could be effective in shrinking or controlling the cancer.

This kind of study is called a 'Phase 1' study, which means it's a very early stage of research. It's usually the first time drugs are tested in people, focusing mostly on safety and finding the right dose. While it's hopeful, it's also important to remember that not all drugs tested in Phase 1 studies go on to become approved treatments. However, each step helps us learn more and potentially offers new hope for patients in the future.

Key takeaways

This study is testing two new drugs for advanced prostate cancer.
It aims to find the safest and most effective dose of these drugs in combination.
It's a Phase 1 study, focusing on safety and dosage.
Designed for men with prostate cancer that has spread and resisted current hormone therapy.
Close monitoring for side effects is a key part of the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is specifically for men aged 18 or older who have advanced prostate cancer that has spread to other parts of the body, like bones or lymph nodes, and is no longer responding to standard hormone therapy. Your prostate cancer must be confirmed by a biopsy, and you should be generally well enough to participate in a study, assessed by a common health score doctors use.

There are also some requirements about your current health and past treatments. For example, your cancer should not have spread to certain organs like the lungs or liver, and any side effects from previous cancer treatments should have mostly cleared up. You would need to be continuing hormone therapy throughout the study. Certain allergies or other serious medical conditions might mean this study isn't right for you at this time.

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 a man aged 18 or older?
Do you have prostate cancer that has spread to your bones or lymph nodes?
Is your prostate cancer no longer responding to hormone therapy?
Are you currently receiving hormone therapy (like injections or tablets)?
Have side effects from any previous cancer treatments mostly gone away?
Do you have good general health, as assessed by your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the investigational drugs, Pasritamig and JNJ-86974680, which are given together. The exact schedule of your visits and how you receive the medication would be explained to you in detail by the study team. You would have regular check-ups, which may include blood tests, scans, and other assessments to monitor your health, how the drugs are affecting you, and how your cancer is responding. These visits are important for the researchers to gather information about the drugs' safety and effectiveness. The total duration of your participation in the study and follow-up will depend on your individual response and the study's protocol, and this would be fully clarified before you join.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. A possible benefit of joining this study is that you might receive a new treatment that could help control your prostate cancer, especially if other treatments haven't worked well. However, because these are new drugs being tested, there's always a risk of unexpected side effects, some of which could be serious. The study team will monitor you very closely for any side effects and will explain all known risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Florida Cancer Specialists
Verified postcode
Sarasota, United States· Recruiting
Columbia University Medical Center
Verified postcode
New York, United States· Recruiting
University Hospitals Cleveland Medical Center
Verified postcode
Cleveland, United States· Recruiting
The Christie NHS Foundation Trust Christie Hospital
Verified postcode
Manchester, United Kingdom· Recruiting
Royal Marsden Hospital
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What does 'advanced prostate cancer' mean in this study?

It means the prostate cancer has spread to other parts of your body, like your bones or lymph nodes, and is no longer responding to standard hormone treatments.

What is a Phase 1 study?

A Phase 1 study is a very early stage of testing new drugs in people. The main goals are to check if the drugs are safe and to find the best dose to use.

Will I know if I'm getting the actual study drugs?

Yes, in this study, all participants will receive the investigational drugs, Pasritamig and JNJ-86974680. There isn't a placebo group in this trial.

What if I have side effects during the study?

The study team will closely monitor you for any side effects. You should report any changes in your health to them immediately, and they will provide care and guidance.

How long will I be in the study?

The length of your participation will depend on how your cancer responds to the treatment and your individual situation. The study team will explain the expected duration to you.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.