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New Immune-Guiding drug shows promise in advanced prostate cancer trial

NCT ID NCT04898634

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug, JNJ-78278343, that helps the body's immune T-cells find and attack prostate cancer cells. It involves 216 men with advanced prostate cancer that has spread. The main goals are to find the safest and most effective dose and to monitor 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

216 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Mar 2027

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: * Confirmed adenocarcinoma of the prostate which has spread to other body parts * Part 1: Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy * Measurable or evaluable disease * Concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks before the first dose of study drug * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Prior surgical removal of testicles; or, for participants who have not undergone surgical removal of testicles, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog Exclusion Criteria: Disease conditions * Active central nervous system (CNS) involvement * Toxicity related to prior anticancer therapy has not adequately recovered Prior/Concomitant Therapy * Prior treatment with human kallikrein (KLK) 2-targeted therapy * Received, or are receiving, medications that suppress the immune system within 3 days prior to the first dose of study drug * Received or plans to receive any live, attenuated vaccine within 4 weeks prior to the first dose of study drug Prior/Concurrent Medical Conditions * Diagnosis of cancer other than prostate cancer within 2 years prior to the first dose of study drug * Solid organ or bone marrow transplantation * Major clotting diseases within one month prior to the first dose of study drug * Active autoimmune disease within 12 months prior to the first dose of study drug * Active infection * Major diseases of heart and blood vessels within 6 months prior to the first dose of study drug * Clinically significant lung diseases * Active or chronic hepatitis B or hepatitis C infection * Known positive test result for human immunodeficiency virus (unless stable on antiretroviral therapy with undetectable viral load) * Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

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

Prostatic neoplasms

Contacts and locations

Locations

  • APHM Hopital Timone

    Marseille, 13005, France

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX, Netherlands

  • Centre Leon Berard

    Lyon, 69373, France

  • Chongqing University Cancer Hospital

    Chongqing, 400030, China

  • Columbia University Medical Center Herbert Irving Pavilion

    New York, New York, 10032, United States

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • First Affiliated Hospital Of Wenzhou Medical College

    Wenzhou, 325399, China

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050, Spain

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Cancer Center Hospital East

    Kashiwa, 277 8577, Japan

  • Peking University Third Hospital

    Beijing, 100191, China

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510710, China

  • University of Washington

    Seattle, Washington, 98195-9472, United States

  • Yokohama City University Medical Center

    Yokohama, 232 0024, Japan

More trials for these conditions

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