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RecruitingPHASE1INTERVENTIONAL

A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer

This research study is investigating two new medicines, JNJ-78278343 and JNJ-95298177, for men with a type of prostate cancer called metastatic castration-resistant prostate cancer (mCRPC). This means the cancer has spread from the prostate gland to other parts of the body and is no longer controlled by standard hormone therapy. The main goals are to find the safest and most effective dose when these two drugs are given together, and to understand any side effects. This is an early-stage study (Phase 1) designed to explore how these new treatments work and how well people tolerate them, with the hope of developing better ways to treat this condition in the future.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Janssen Research & Development, LLC
Enrolment target
140
Start
07 Jul 2025
Estimated completion
01 Mar 2027

What is this study about?

This study is looking into new ways to treat advanced prostate cancer. When prostate cancer spreads to other parts of the body and no longer responds to hormone treatments, it's called metastatic castration-resistant prostate cancer (mCRPC). This can be a challenging form of cancer to treat, so researchers are always looking for new medications.

In this study, doctors are testing two new investigational drugs, JNJ-78278343 and JNJ-95298177, to see how they work together. The beginning part of the study (Part 1) aims to find the right amount, or 'dose', of each medicine to give when they are combined. This is a very important step to make sure the treatment is as safe and effective as possible. Once the best dose is found, more people will join the study (Part 2) to help researchers understand more about the safety and how well people tolerate this combined treatment.

The overall aim is to gather important information about these new medicines. By understanding more about their safety and possible benefits, doctors hope to develop new and improved treatments for men living with metastatic castration-resistant prostate cancer, offering new options where existing treatments might no longer be effective.

Key takeaways

  • This study is for advanced prostate cancer that has spread and is resistant to hormone therapy.
  • It tests two new medicines, JNJ-78278343 and JNJ-95298177, together.
  • The main goals are to find the right dose and understand the safety of this combination.
  • It's an early-stage study (Phase 1) looking for new treatment possibilities.
  • Participants must meet specific health and cancer criteria.

Who may be eligible?

To be considered for this study, you must be a male aged 18 or older with a confirmed diagnosis of prostate cancer that has spread and is resistant to hormone therapy. Your cancer must be a specific type called adenocarcinoma. You would also need to be generally well, able to perform daily activities with ease, and have certain blood test results and a specific level of PSA (a protein in the blood linked to prostate cancer).

There are also reasons why you might not be able to join. For example, if you have certain other serious medical conditions like specific brain issues, or if you've recently had other cancer treatments that caused severe side effects that haven't cleared up. You also can't be allergic to any ingredients in the study medicines. The team will carefully check all your medical information to see if this study is suitable for you.

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.

  1. Are you a man aged 18 or older?
  2. Do you have prostate cancer that has spread and no longer responds to hormone treatment?
  3. Is your prostate cancer specifically an adenocarcinoma type?
  4. Are you generally well and able to manage daily activities?
  5. Have you discussed your brain health with your doctor if you've had brain metastases?
  6. Are you currently on or willing to continue hormone therapy if you haven't had an orchiectomy?
Answer every question to see your result.

What does participation involve?

Information about what taking part in this study involves isn't fully detailed in the summary provided. However, typically in a study like this (Phase 1), you would likely have regular visits to the hospital or clinic. During these visits, you would receive the study medication (JNJ-78278343 and JNJ-95298177), undergo various tests to check your health, such as blood tests, scans, and physical examinations. These tests help the doctors monitor how your body is responding to the treatment and check for any side effects. You would also have follow-up appointments after the main treatment phase to continue monitoring your health. The total duration of your participation would be explained in full by the study team, but Phase 1 studies often involve intensive monitoring over several months.

Potential risks and benefits

Taking part in a clinical study offers the potential benefit of accessing new treatments before they are widely available, which might help control your cancer if current treatments are no longer effective. However, there are potential risks, as these are new medications and their full side effects are not yet known. You might experience side effects that range from mild to serious. The research team will carefully monitor you for any issues and address them promptly. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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
  • Fred Hutchinson Cancer Center
    Verified postcode
    Seattle, United States· Recruiting
  • The Christie Nhs Foundation Trust
    Verified postcode
    Manchester, United Kingdom· Recruiting
  • Royal Marsden Hospital (Sutton)
    Verified postcode
    Sutton, United Kingdom· Recruiting

Common questions

What kind of cancer is this study for?

This study is for prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone treatments. Doctors call this metastatic castration-resistant prostate cancer.

What are JNJ-78278343 and JNJ-95298177?

These are the names of two new investigational medicines being tested in this study. They are not yet approved for general use but are being investigated as a potential new treatment for prostate cancer.

What is a 'Phase 1' study?

A Phase 1 study is an early stage of clinical research. Its main goal is to find the safest and most effective dose of a new drug or combination of drugs, and to look for any side effects.

Will I know if I'm getting the active drugs?

In this early phase study, everyone taking part is expected to receive the study drugs (JNJ-78278343 and JNJ-95298177). There will not be a placebo group.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your normal medical care.

How to find out more

Study Contact

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of JNJ-78278343 in Combination With JNJ-95298177 for…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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