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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
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

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Greenslopes Private Hospital
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GreenslopesAustraliaRecruiting
Peter MacCallum Cancer Centre
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MelbourneAustraliaRecruiting
Chongqing University Cancer Hospital
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ChongqingChinaRecruiting
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
The Cancer Institute Hospital of JFCR
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TokyoJapanRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsWithdrawn
Emory University/Winship Cancer Institute
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AtlantaUnited StatesRecruiting
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesRecruiting
Atrium Health Levine Cancer Institute
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CharlotteUnited StatesRecruiting
START - New Jersey
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East BrunswickUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
University of Minnesota
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MinneapolisUnited StatesRecruiting
Tennessee Oncology
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NashvilleUnited StatesRecruiting
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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New YorkUnited StatesRecruiting
Sidney Kimmel Cancer Center - Jefferson Health
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PhiladelphiaUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesRecruiting
South Texas Accelerated Research Therapeutics, LLC (START)
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San AntonioUnited StatesRecruiting
Swedish Medical Center
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SeattleUnited StatesRecruiting
Montefiore Medical Center
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The BronxUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.