Tests two experimental antibody drugs together in men with advanced prostate cancer
Tests two experimental antibody drugs, given together, in adults with advanced prostate cancer.
Key facts
- Who runs it
- Janssen Research & Development, LLC
- Where
- Atlanta, Aurora, Charlotte, East Brunswick, Houston, Minneapolis, Nashville, New York, Philadelphia, Portland, San Antonio, Seattle, and The Bronx, United StatesSee the 13 sitesAlso in 5 other countries, 10 sites
- Trial code
- Registry title
- A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 355 people, planned
- Started
- 1 Nov 2023
- Expected to end
- 28 Jun 2028
- Type of study
- Interventional, 4 groups
- Treatments tested
- JNJ-78278343
- JNJ-87189401
- Apalutamide
- Lutetium Lu-177 Vipivotide Tetraxetan
- JNJ-101556143
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with advanced prostate cancer (adenocarcinoma) who are on androgen deprivation therapy or have had surgical castration, and who are fairly active (ECOG 0 or 1).
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Advanced prostate cancer; adenocarcinoma of the prostate confirmed under the microscope, with measurable or evaluable disease. Small cell or neuroendocrine features are allowed.
- Earlier treatment
- Prior orchiectomy (surgical castration) or medical castration. Men without orchiectomy must be on ongoing androgen deprivation therapy with a GnRH analog before the first dose and keep taking it during treatment.
Main reasons for not taking part
- Small cell carcinoma, carcinoid tumor, mixed neuroendocrine carcinoma or large cell neuroendocrine carcinoma
- An autoimmune disease in the last 12 months
- In the last 6 months: heart attack, severe or unstable angina, or serious heart rhythm problems
- In the last 6 months: congestive heart failure (NYHA class II to IV)
- In the last 6 months: transient ischemic attack or stroke
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
Also in 5 other countries, 10 sites
- Emory University/Winship Cancer InstituteAtlanta, United StatesTaking people
- University of Colorado Anschutz Medical CampusAurora, United StatesTaking people
- Atrium Health Levine Cancer InstituteCharlotte, United StatesTaking people
- START - New JerseyEast Brunswick, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- University of MinnesotaMinneapolis, United StatesTaking people
- Tennessee OncologyNashville, United StatesTaking people
- Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterNew York, United StatesTaking people
- Sidney Kimmel Cancer Center - Jefferson HealthPhiladelphia, United StatesTaking people
- Oregon Health and Science UniversityPortland, United StatesTaking people
- South Texas Accelerated Research Therapeutics, LLC (START)San Antonio, United StatesTaking people
- Swedish Medical CenterSeattle, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Part 1 (Dose Escalation)Treatment being tested
Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R).
Treatment: JNJ-78278343 and JNJ-87189401
- Part 2 (Dose Expansion)Treatment being tested
Participants with different disease settings in Parts 2A and 2B will receive JNJ-78278343+JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will receive apalutamide plus continued treatment with JNJ-87189401+JNJ-78278343 doublet.
Treatment: JNJ-78278343, JNJ-87189401, and Apalutamide
- Part 3Treatment being tested
Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) selected in Part 1 along with standard of care (SOC) treatment with lutetium Lu-177 vipivotide tetraxetan. Dosing of JNJ-78278343+JNJ-87189401 will be escalated sequentially, as per study evaluation team (SET) decision.
Treatment: JNJ-78278343, JNJ-87189401, and Lutetium Lu-177 Vipivotide Tetraxetan
- Part 4Treatment being tested
Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) along with JNJ-101556143. Dosing of JNJ-78278343+JNJ-87189401 along with JNJ-101556143 will be escalated sequentially to determine the RP2R of the combinations.
Treatment: JNJ-78278343, JNJ-87189401, and JNJ-101556143
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
- Plain-language title
- Tests two experimental antibody drugs together in men with advanced prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 November 2026