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

Official record

Identifier

NCT06095089

Recruiting locations

countries

United StatesAustraliaChinaFranceJapan

Interventions studied

JNJ-78278343JNJ-87189401ApalutamideLutetium Lu-177 Vipivotide TetraxetanJNJ-101556143

Lead sponsor

Janssen Research & Development, LLC

Target enrolment

355 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Recruiting

First posted

Oct 23, 2023

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

MALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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