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New antibody combo aims to control advanced prostate cancer

NCT ID NCT06095089

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This early-phase study tests two experimental drugs (JNJ-87189401 and JNJ-78278343) that help the immune system attack prostate cancer cells. The study involves about 355 men with advanced prostate cancer. The main goal is to find the safest dose and check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 355 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed * Measurable or evaluable disease per PCWG3 criteria * Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * History of an autoimmune disease within the 12 months prior to signing consent * Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association \[NYHA\] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma prostate neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced prostate cancer Prostatic neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Centre Leon Berard

    RECRUITING

    Lyon, 69008, France

  • Emory University Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Greenslopes Private Hospital

    RECRUITING

    Greenslopes, 4120, Australia

  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Institut Bergonie

    RECRUITING

    Bordeaux, 33000, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Oregon Health And Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, 3000, Australia

  • START New Jersey

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Sidney Kimmel Cancer Center - Jefferson Health

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • South Texas Accelerated Research Therapeutics, LLC (START)

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Swedish Medical Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Tokyo, 135 8550, Japan

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, 325000, China

  • University Of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.