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

  • Research type

    Research Study

  • Full title

    A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination with JNJ-95298177, an Antibody Drug Conjugate Targeting Prostate Specific Membrane Antigen, for Prostate Cancer.

  • IRAS ID

    1011800

  • Contact name

    Elena Bolanos Cascales

  • Contact email

    GCOUKSubmissions@its.jnj.com

  • Sponsor organisation

    Janssen - Cilag International

  • ISRCTN Number

    ISRCTN11926317

  • Research summary

    Prostate cancer is a cancer that forms in the prostate, a male reproductive gland found below the bladder. Cancer is considered “advanced” if it spreads extensively to other parts of the body. Although treatments are available, they do not cure cancer. Over time, disease gets worse and progresses to metastatic castration-resistant prostate cancer (mCRPC)*, showing the need for better treatment.
    *prostate cancer that grows despite low levels of male hormones JNJ-78278343 is a bispecific antibody** that targets a protein, human kallikrein 2, on tumor cells and cluster of differentiation 3 protein on T-cells (key cell in the immune system). This activates T-cells,
    which damage tumor cells and stop them from growing.
    **type of protein that recognizes and attaches to 2 different targets
    JNJ-95298177 is an antibody drug conjugate*** that targets proteins present on the surface of
    cancer cells. Once it attaches, it enters the cell and delivers a cancer-fighting drug, which stops the
    cancer from growing.
    ***treatment combining antibody with drug to attack cancer cells
    In this study, researchers want to identify the most suitable dose of JNJ-78278343 and JNJ-95298177
    and to find out how safe it is at the recommended dose.

  • REC name

    North West - Haydock Research Ethics Committee

  • REC reference

    25/NW/0170

  • Date of REC Opinion

    7 Jul 2025

  • REC opinion

    Further Information Favourable Opinion