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RECRUITING Phase 1 ClinicalTrials.gov

A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT06095089

Registry updated: 2026-09-28
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Description

The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.

Interventions

  • JNJ-78278343 (Drug)
    JNJ-78278343 will be administered.
  • JNJ-87189401 (Drug)
    JNJ-87189401 will be administered.
  • Apalutamide (Drug)
    Apalutamide will be administered.
  • Lutetium Lu-177 Vipivotide Tetraxetan (Drug)
    Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.
  • JNJ-101556143 (Drug)
    JNJ-101556143 will be administered.

Eligibility criteria

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

Conditions

Prostatic Neoplasms

Locations

  • University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
  • Emory University Winship Cancer Institute — Atlanta, Georgia, United States
  • University Of Minnesota — Minneapolis, Minnesota, United States
  • START New Jersey — East Brunswick, New Jersey, United States
  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center — New York, New York, United States
  • Atrium Health Levine Cancer Institute — Charlotte, North Carolina, United States
  • Oregon Health And Science University — Portland, Oregon, United States
  • Sidney Kimmel Cancer Center - Jefferson Health — Philadelphia, Pennsylvania, United States
  • Tennessee Oncology — Nashville, Tennessee, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • South Texas Accelerated Research Therapeutics, LLC (START) — San Antonio, Texas, United States
  • Swedish Medical Center — Seattle, Washington, United States
  • Greenslopes Private Hospital — Greenslopes, Australia
  • Peter MacCallum Cancer Centre — Melbourne, Australia
  • Chongqing University Cancer Hospital — Chongqing, China
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China
  • Institut Bergonie — Bordeaux, France
  • Centre Leon Berard — Lyon, France
  • Institut Gustave Roussy — Villejuif, France
  • The Cancer Institute Hospital of JFCR — Tokyo, Japan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record