RecruitingPhase IInterventional

A study of JNJ-78278343 in combination with JNJ-95298177 for treatment of prostate cancer

This study is looking at two new medicines, JNJ-78278343 and JNJ-95298177, given together for men with advanced prostate cancer. This is called metastatic castration-resistant prostate cancer, which means the cancer has spread and isn't responding well to hormone treatments. Both medicines are designed to fight cancer in different ways; one helps your immune system target cancer cells, and the other delivers a powerful drug directly to the cancer cells. This is an early-stage study (Phase 1) focused on finding the best dose of the combination and checking if it's safe. While participants may not directly benefit, the information learned could help future patients with this type of prostate cancer.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Janssen-Cilag International NV

Enrolment target

140

Start

17 Jul 2025

Estimated completion

31 Dec 2026

Prostate cancer

What is this study about?

Prostate cancer starts in the prostate gland, which is part of the male reproductive system. When cancer spreads widely to other parts of the body, it's called advanced prostate cancer. Even with available treatments, prostate cancer can sometimes continue to grow, leading to a condition called metastatic castration-resistant prostate cancer (mCRPC). This happens when the cancer grows even though male hormone levels are kept very low. Finding better treatments for this stage of prostate cancer is very important.

This study is testing two new experimental medicines, JNJ-78278343 and JNJ-95298177, given together. JNJ-78278343 is designed to help your body's immune system fight the cancer. It works by making your immune cells, called T-cells, recognise and attack the cancer cells. JNJ-95298177 is a different type of medicine that specifically targets cancer cells and delivers a cancer-fighting drug directly into them, stopping them from growing. Researchers hope that combining these two approaches might be more effective in treating advanced prostate cancer.

Because these medicines are being tested together for the first time in people, this is an early-stage (Phase 1) study. The main goals are to find the right and safest dose of the combined medicines and to learn more about how safe they are. The study will also start to look at how well the combination works against the cancer. The information gathered from this study is crucial for deciding if these new treatments can be developed further to help more people in the future.

Key takeaways

This study is testing a new combination of two medicines for advanced prostate cancer.
It's an early-stage study focused on finding the right dose and checking safety.
The medicines work in different ways to target and fight cancer cells.
Participants may not directly benefit, but the study helps future prostate cancer patients.
Close monitoring for side effects is a key part of participating.
The study duration is planned for around 2 years and 2 months.

Who may be eligible?

This study is looking for men who have prostate cancer that has spread to other parts of the body and is still growing despite hormone treatments. Your cancer must be a specific type (adenocarcinoma of the prostate) and have certain levels of a marker called PSA in your blood.

You also need to be well enough to take part, meaning you can generally look after yourself and do most daily activities. You must also be receiving ongoing hormone therapy or have had your testicles removed.

There are some reasons why you might not be able to join. For example, if you have certain other serious health problems, or if you've recently had other cancer treatments that caused severe side effects that haven't gone away. If you are allergic to any parts of the study drugs or have specific types of brain metastases, you would also not be able 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 a man with prostate cancer that has spread?
Is your prostate cancer still growing despite hormone treatments?
Do you have a specific type of prostate cancer called adenocarcinoma?
Are you generally well enough to manage daily activities?
Are you able to continue hormone therapy if you haven't had an orchiectomy?
Do you have any severe ongoing side effects from previous cancer treatments?

Answer every question to see your result.

What does participation involve?

If you join this study, it will be carried out in two main parts. In the first part, called "Dose Confirmation," you'll receive doses of both JNJ-78278343 and JNJ-95298177. The aim here is to make sure the combined doses are safe. Once the best doses are confirmed, the study will move to the second part, "Dose Expansion." In this part, you'll continue to receive the confirmed doses of both medicines so the researchers can further check their safety and how well they work against the cancer.

Throughout the study, you'll have regular check-ups to monitor your health. These will include physical examinations, checking your heart activity with an ECG, and taking blood and urine samples for lab tests. The healthcare team will also assess how well you are managing your daily activities and generally feeling. All potential side effects will be carefully monitored and recorded. The study is expected to last for around 2 years and 2 months. You will be encouraged to discuss any new or worrying symptoms with your study doctor.

Potential risks and benefits

It's important to know that you might not directly benefit from taking part in this early-stage study. However, the information learned could be very helpful for people with advanced prostate cancer in the future. This is the first time these two medicines have been given together to people, although each has been tested separately. Potential side effects could include an inflammatory reaction known as cytokine release syndrome, headaches, changes in mental state, or seizures, and reactions during the infusion like chills or shortness of breath. For those with a prostate, inflammation of the prostate could occur. Other possible risks include kidney or liver problems, nerve damage, lung inflammation, or a low number of blood platelets, which can affect bleeding. You will receive a detailed information sheet outlining all known and potential risks. These side effects can range from mild to severe, and some might be unexpected. Your healthcare team will closely monitor you for any side effects and provide care. You have the right to leave the study at any time.

Locations (6)

The Christie NHS Foundation Trust
City only
Manchester, England
The Royal Marsden Hospital (surrey)
City only
Sutton, England
University Hospitals Cleveland Medical Center
Approximate
Cleveland, United States of America
Florida Cancer Specialists
City only
Sarasota, United States of America
Fred Hutchinson Cancer Center
Approximate
Seattle, United States of America
Columbia University Medical Center
Unverified
New York, United States of America

Common questions

What is prostate cancer?

Prostate cancer is a type of cancer that starts in the prostate, a gland in men below the bladder.

What does 'advanced' or 'metastatic' mean?

It means the cancer has spread from the prostate to other parts of the body.

What kind of medicines are being tested?

Two new medicines, JNJ-78278343 and JNJ-95298177, are being tested together. They fight cancer in different ways.

What is the main goal of this study?

The main goal is to find the safest dose of these combined medicines and see how safe they are in general.

How long will the study last?

The study is expected to last about 2 years and 2 months.

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.