Actively Recruiting
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
355
Participants Needed
15
Research Sites
53 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying advanced prostate cancer by evaluating combinations of investigational drugs JNJ-87189401 and JNJ-78278343, with or without other treatments like apalutamide, lutetium Lu-177 vipivotide tetraxetan, and JNJ-101556143. This study aims to determine the recommended dosing regimens and assess the safety of these drug combinations in different parts of the trial, including dose escalation and expansion phases. Participants will receive escalating doses of JNJ-78278343 combined with JNJ-87189401 in Part 1 to find the best dose for Phase 2. In Parts 2A and 2B, participants receive this combination at the selected dose. Part 2C adds apalutamide to the combination. Part 3 evaluates the combination with standard care lutetium Lu-177 vipivotide tetraxetan, and Part 4 studies the combination with JNJ-101556143. Dosing adjustments are made based on safety and evaluation team decisions. During the study, participants will be monitored for dose-limiting toxicities and adverse events up to nearly five years. Researchers will measure drug concentrations in blood, immune response to the drugs, tumor response, progression-free survival, and prostate-specific antigen levels. Participants undergo regular safety assessments and follow-up visits throughout the study, which started in November 2023 and continues through June 2028.
CONDITIONS
Brief Title
A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate, including adenocarcinoma with small cell or neuroendocrine features
- Measurable or evaluable disease according to PCWG3 criteria
- Prior orchiectomy or ongoing androgen deprivation therapy with a gonadotropin releasing hormone analog before first study drug dose and continuing during treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Male participants aged 18 years or older
You will not qualify if you...
- History of autoimmune disease within 12 months before signing consent
- Within 6 months before consent: myocardial infarction, severe or unstable angina, clinically significant ventricular arrhythmias, congestive heart failure (NYHA class II to IV), transient ischemic attack, or cerebrovascular accident
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 21 days after first combination dose
Participants receive escalating doses of JNJ-78278343 and JNJ-87189401 to select a recommended Phase 2 regimen.
Duration - Up to 4 years and 8 months
Participants receive selected doses of JNJ-78278343 and JNJ-87189401, sometimes combined with apalutamide, lutetium Lu-177 vipivotide tetraxetan as standard of care treatment, or JNJ-101556143 based on study part assignment.
Trial Site Locations
Total: 15 locations
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
University Of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
4
START New Jersey
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
5
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
6
Oregon Health And Science University
Portland, Oregon, United States, 97239
Actively Recruiting
7
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
8
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, United States, 78229
Actively Recruiting
11
Swedish Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
12
Institut Bergonie
Bordeaux, France, 33000
Actively Recruiting
13
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
14
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
15
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135 8550
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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