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

RecruitingPhase 1Ages 18 Years - anyMaleJanssen Research & Development, LLC
NCT06095089 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • JNJ-78278343
  • JNJ-87189401
  • Apalutamide
  • Lutetium Lu-177 Vipivotide Tetraxetan
  • JNJ-101556143
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Where

20 sites
University of Colorado Anschutz Medical Campus
Aurora, United States
Emory University Winship Cancer Institute
Atlanta, United States
University Of Minnesota
Minneapolis, United States
START New Jersey
East Brunswick, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, United States
Atrium Health Levine Cancer Institute
Charlotte, United States
Oregon Health And Science University
Portland, United States
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, United States

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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