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RecruitingLast updated: 6 August 2026

CR109330: Evaluating new immunotherapy combinations for people with advanced prostate cancerA Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

CR109330

Clinical summary

Summary

This study is testing new combinations of treatments for people with advanced prostate cancer.

This trial may be suitable for people with advanced prostate cancer. Some parts of the study are for people who are receiving hormone therapy to lower testosterone levels or who have previously had an orchiectomy. Eligibility requirements may vary between different parts of the study, so speak with the trial team about whether you may be eligible.

Researchers are evaluating two investigational immunotherapy medicines, JNJ-87189401 and JNJ-78278343, to find the most appropriate dose and treatment schedule and learn more about their side effects.

The study will also assess whether these medicines can be safely combined with other prostate cancer treatments, including:

  • hormone therapy (apalutamide),
  • targeted radioactive therapy (lutetium Lu-177 vipivotide tetraxetan), and
  • another investigational medicine (JNJ-101556143).

The aim is to identify treatment combinations that may be suitable for further clinical testing. 

 

Conditions

This trial is treating people with advanced prostate cancer

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You are currently receiving treatment for your cancer.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06095089 *
  • 2023-504063-17-00 *
  • CR109330; 87189401PCR1001

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

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