A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
- Prostatic Neoplasms
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 355
- Started
- 1 November 2023
- Main results due
- 21 June 2027
- Study sites
- 20
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Men only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(20)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Recruiting
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
University Of Minnesota
Minneapolis, Minnesota, United States
Recruiting
START New Jersey
East Brunswick, New Jersey, United States
Recruiting
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States
Recruiting
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
Recruiting
Oregon Health And Science University
Portland, Oregon, United States
Recruiting
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States
Recruiting
Tennessee Oncology
Nashville, Tennessee, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, United States
Recruiting
Swedish Medical Center
Seattle, Washington, United States
Recruiting
Greenslopes Private Hospital
Greenslopes, Australia
Recruiting
Peter MacCallum Cancer Centre
Melbourne, Australia
Recruiting
Chongqing University Cancer Hospital
Chongqing, China
Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Recruiting
Institut Bergonie
Bordeaux, France
Recruiting
Centre Leon Berard
Lyon, France
Recruiting
Institut Gustave Roussy
Villejuif, France
Recruiting
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Recruiting
Showing 20 of 20 sites. 20 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06095089. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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