CompletedPhase IInterventional

A study of Pasritamig (JNJ-78278343) in combination with JNJ-86974680 for treatment of prostate cancer

This study is looking at a new combination of two drugs, Pasritamig and JNJ-86974680, for men with advanced prostate cancer. Prostate cancer is considered advanced when it has spread beyond the prostate, and current treatments don't offer a cure. Pasritamig works by helping your body's immune cells find and attack cancer cells, while JNJ-86974680 helps keep these immune cells active. This is an early-stage study (Phase 1) focused on finding a safe dose and understanding any side effects. Participants will be closely monitored, and while there might not be a direct benefit to them, the information gained could help future patients.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Janssen-Cilag International NV

Enrolment target

Start

14 Jan 2026

Estimated completion

22 May 2026

Prostate cancer

What is this study about?

Prostate cancer starts in the prostate gland, which is part of the male reproductive system. When this cancer spreads to other parts of the body, it's called advanced prostate cancer. Even with available treatments, advanced prostate cancer can be challenging, often continuing to grow even when hormone levels are kept low. This means there's a real need for new and more effective treatments.

This study is testing a new way to fight prostate cancer using a combination of two drugs: Pasritamig and JNJ-86974680. Pasritamig is a special type of drug designed to help your immune system attack cancer cells. Think of it like a guide that helps your body's natural defender cells (called T-cells) spot and destroy the cancer. JNJ-86974680 works by keeping these immune cells active and ready to fight, preventing them from 'getting tired' and giving up.

Because these are new drugs being tested together for the first time in people, the main goals of this early-stage study (called Phase 1) are to find the safest and most suitable dose for this combination treatment. Researchers will also be carefully watching for any side effects and looking for early signs of how well the treatment works against the cancer. The study will be run by Janssen-Cilag International NV and is expected to start in January 2026, running until June 2028.

Key takeaways

This study is testing two new drugs, Pasritamig and JNJ-86974680, together for advanced prostate cancer.
It's an early-stage (Phase 1) trial focused on finding a safe dose and understanding side effects.
The drugs aim to activate your immune system to fight cancer cells.
Participation involves regular check-ups and monitoring for about 14 months.
There may not be direct benefit to you, but the information gained could help future patients.
You can withdraw from the study at any time.

Who may be eligible?

This study is specifically for men who have been diagnosed with prostate cancer that has been confirmed in a lab test to be a common type called adenocarcinoma. Your cancer must have spread to other parts of your body, such as bones or lymph nodes, and it must still be growing even though treatments to lower male hormones are being used.

You would need to be currently receiving treatment to lower your male hormone levels and have a certain level of a prostate cancer marker called PSA in your blood. You should also be generally well enough to look after yourself and carry out light activities, as measured by a score called ECOG performance status.

You would not be able to join if you have certain other conditions, such as an active infection requiring strong antibiotics, or if you have specific types of brain metastases. Also, if you have severe side effects from previous cancer treatments that haven't improved to a mild level, you might not be eligible. Any known allergies to the study drugs would also prevent participation.

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.

I have been diagnosed with adenocarcinoma of the prostate.
My prostate cancer has spread to other parts of my body, like bones or lymph nodes.
My cancer is still progressing despite treatments to lower male hormones.
I am currently receiving ongoing hormone-lowering therapy.
I am generally well and able to care for myself.
I am male and 18 years or older.

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve two main stages. In the first stage, a small number of participants will receive different doses of Pasritamig and JNJ-86974680. The aim here is to find the safest and most effective dose to use. Once that dose is chosen, more participants will join the second stage of the study to receive this recommended dose.

Throughout the study, you will have regular check-ups to monitor your health and how you are responding to the treatment. These will include physical examinations, measuring your vital signs (like heart rate and blood pressure), blood tests, and heart tracings (ECGs). Researchers will also check how well you're managing daily activities. All potential side effects will be carefully recorded up until the study ends, which is expected to be around 1 year and 2 months after treatment begins for each participant.

Potential risks and benefits

It's important to understand that you might not personally benefit from taking part in this early-stage study, as the main goal is to gather information. However, the knowledge gained could be very valuable in helping future patients with advanced prostate cancer. There are potential risks, as this is the first time these two drugs are being used together in people. Pasritamig may cause an immune reaction called cytokine release syndrome (flu-like symptoms), nerve-related effects like headaches or changes in mental state, or reactions during the infusion like chills or shortness of breath. JNJ-86974680 may increase feelings of sickness (nausea) and vomiting, and affect liver enzymes. There's also a chance of inflammation in the prostate. Researchers will closely monitor you for any side effects, which can range from mild to severe, and some might be unexpected. You can discuss any concerns with your study doctor, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (5)

The Christie
Approximate
Manchester, England
Royal Marsden Hospital
Approximate
Sutton, England
Florida Cancer Specialists
City only
Sarasota, United States of America
Columbia University Medical Centre
City only
New York, United States of America
University Hospitals Cleveland
Approximate
Cleveland, United States of America

Common questions

What is advanced prostate cancer?

Advanced prostate cancer means the cancer has spread from the prostate gland to other parts of your body, such as your bones or lymph nodes.

What kind of drugs are Pasritamig and JNJ-86974680?

Pasritamig helps your immune system target and attack cancer cells. JNJ-86974680 helps keep these immune cells active to fight the cancer more effectively.

Is this a new treatment?

Yes, this is a very early-stage study (Phase 1) testing these two drugs in combination for the first time in people.

How long will the study last?

The study itself runs from January 2026 to June 2028. If you participate, you will be monitored for about 1 year and 2 months.

Who is paying for this research?

The study is funded by Janssen-Cilag International NV, a pharmaceutical company.

How to find out more

Larissa Bates

janssenukregistryqueries@its.jnj.com - Official trial record

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