NCT06095089RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 355 (estimated)
- First submitted
- 18 Oct 2023
- Start date
- 1 Nov 2023
- Primary completion date
- 21 Jun 2027
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Prostate cancer
- NCT number
- NCT06095089
- EU CT number
- 2023-504063-17-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 355
- From 1 Nov 2023 to the primary completion date, 21 Jun 2027
- 23 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Greenslopes Private Hospital Coordinator of this site? Confirm its status | Greenslopes | Australia | Recruiting |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| The First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Withdrawn |
| Emory University/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Atrium Health Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| START - New Jersey Coordinator of this site? Confirm its status | East Brunswick | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Herbert Irving Comprehensive Cancer Center Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Sidney Kimmel Cancer Center - Jefferson Health Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| South Texas Accelerated Research Therapeutics, LLC (START) Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Swedish Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.