A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

Last updated: May 22, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

JNJ-78278343

Clinical Study ID

NCT04898634
CR108958
78278343PCR1001
2020-005970-83
2023-506585-31-00
  • Ages > 18
  • Male

Study Summary

The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion).

Eligibility Criteria

Inclusion

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)-targetedtherapy or chemotherapy

  • Measurable or evaluable disease

  • Concurrent use of any other anticancer treatment must be discontinued for at least 2weeks 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 undergonesurgical removal of testicles, must be receiving ongoing androgen deprivationtherapy (ADT) with a gonadotropin releasing hormone analog

Exclusion

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 3days prior to the first dose of study drug

  • Received or plans to receive any live, attenuated vaccine within 4 weeks prior tothe first dose of study drug

Prior/Concurrent Medical Conditions

  • Diagnosis of cancer other than prostate cancer within 2 years prior to the firstdose 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 ofstudy drug

  • Clinically significant lung diseases

  • Active or chronic hepatitis B or hepatitis C infection

  • Known positive test result for human immunodeficiency virus (unless stable onantiretroviral therapy with undetectable viral load)

  • Any serious underlying medical conditions or other issue that would impair theability of the participant to receive or tolerate the planned treatment

Study Design

Total Participants: 260
Treatment Group(s): 1
Primary Treatment: JNJ-78278343
Phase: 1
Study Start date:
July 13, 2021
Estimated Completion Date:
February 16, 2026

Connect with a study center

  • Peking University Third Hospital

    Beijing, 100191
    China

    Active - Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400030
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Center

    Guang Zhou Shi, 510710
    China

    Active - Recruiting

  • Sun Yat-Sen University Cancer Center

    Guang Zhou Shi, 510710
    China

    Active - Recruiting

  • First Affiliated Hospital Of Wenzhou Medical College

    Wen Zhou Shi, 325399
    China

    Active - Recruiting

  • Centre Leon Berard

    Lyon Cedex 8, 69373
    France

    Active - Recruiting

  • Centre Leon Bérard

    Lyon Cedex 8, 69373
    France

    Active - Recruiting

  • APHM Hopital Timone

    Marseille, 13005
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800
    France

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277 8577
    Japan

    Active - Recruiting

  • Yokohama City University Medical Center

    Yokohama, 232 0024
    Japan

    Active - Recruiting

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX
    Netherlands

    Completed

  • NKI AVL Amsterdam

    Amsterdam, 1066 CX
    Netherlands

    Completed

  • NKI-AVL, Amsterdam

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hosp. Univ. Fund. Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hosp. Univ. Hm Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hosp Virgen de La Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hosp. Virgen de La Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Columbia University Medical Center Herbert Irving Pavilion

    New York, New York 10032
    United States

    Active - Recruiting

  • Columbia University Medical Center, Herbert Irving Pavilion

    New York, New York 10032
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98195-9472
    United States

    Active - Recruiting

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