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A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
Trial Status: active
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06095089.
