A Phase 1 interventional study of JNJ-78278343 and JNJ-87189401 in Prostatic Neoplasms, sponsored by Janssen Research & Development, LLC. Recruiting at 22 sites in 5 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
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Among 88 studies in Prostatic Neoplasms by Johnson & Johnson — 9 open to participants now, 23 under way, 9 of them phase 3. Prostatic Neoplasms · Johnson & Johnson.
Among the 88 studies in Prostatic Neoplasms by Johnson & Johnson, this one is the 13th largest by planned enrollment of the 68 interventional ones that give a count, is one of 4 that started in 2023, is one of 27 in phase 1, reaches primary completion later than 14 of the 22 other live ones, and was the 81st registered.
7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →9 of the 88 studies in Prostatic Neoplasms by Johnson & Johnson are open now, in 8 countries. Recruiting first, the newest first:
Janssen Research & Development, LLC · Sites in United States, Israel
Ages 18+ · Men only
Janssen Research & Development, LLC · Sites in United States, Australia, China and 1 more country
Ages 18+ · Men only
Janssen Research & Development, LLC · Sites in United States, Israel
Ages 18+ · Men only
Janssen Research & Development, LLC · Sites in United States, United Kingdom
Ages 18+
Janssen Cilag S.A.S. · Sites in France
Ages 18+ · Men only
By country, each count listing its studies:
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
88 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 31 · Phase 2 24 · Phase 3 15 · Phase 4 2
First in 1995; this study’s year is marked. 4 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 355 is above the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 82 across the 68 interventional studies, 300 across the 16 observational. Of the 58 that completed or were terminated, 24 (41%) have results posted.
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This study is registered under Janssen Research & Development, LLC, one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 137 (48%) have results posted.
9 of the studies in Prostatic Neoplasms by Johnson & Johnson that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03767244Phase 3Janssen Research & Development, LLCA Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | 2026-12-01 |
| NCT02531516Phase 3Aragon Pharmaceuticals, Inc.An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS | 2027-03-01 |
| NCT04644770Janssen Research & Development, LLCA Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer | 2026-12-08 |
| NCT04662580Janssen Research & Development, LLCARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer | 2026-12-31 |
| NCT07319871Janssen Research & Development, LLCA Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer | 2027-01-07 |
Add all 9 to your calendar (.ics) → With an account.
Among the 88 studies in Prostatic Neoplasms by Johnson & Johnson, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R).
Drug: JNJ-78278343 · Drug: JNJ-87189401
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.
Drug: JNJ-78278343 · Drug: JNJ-87189401 · Drug: Apalutamide
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.
Drug: JNJ-78278343 · Drug: JNJ-87189401 · Drug: Lutetium Lu-177 Vipivotide Tetraxetan
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.
Drug: JNJ-78278343 · Drug: JNJ-87189401 · Drug: JNJ-101556143
JNJ-78278343 will be administered.
Also known as: KLK2-CD3, Pasritamig
JNJ-87189401 will be administered.
Also known as: PSMAxCD28
Apalutamide will be administered.
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.
JNJ-101556143 will be administered.
Also known as: HLD-0915
Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Time frame: Up to 21 days after first combination dose of study drugs
Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Time frame: Up to 4 years 8 months
Serum Concentrations of JNJ-87189401 and JNJ-78278343
Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343.
Time frame: Up to 4 years 8 months
Plasma Concentration of JNJ-101556143
Plasma samples will be analyzed to determine concentrations of JNJ-101556143.
Time frame: Up to 4 years 8 months
Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported.
Time frame: Up to 4 years 8 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or better according to response evaluation criteria in solid tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
Time frame: Up to 4 years 8 months
Radiographic Progression-Free Survival (rPFS)
rPFS is defined time from the date of first dose of study drug until the date of objective disease progression or death, whichever comes first.
Time frame: Up to 4 years 8 months
Prostate Specific Antigen (PSA) Response Rate
PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.
Time frame: Up to 4 years 8 months
Duration of Response (DOR)
DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.
Time frame: Up to 4 years 8 months
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Jun 2027, 43 months after the start.
Of 212 industry-sponsored phase 1 interventional studies under Prostatic Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 62. This study's planned 43 months is above that.
Counting every sponsor, half of 456 studies reached it within 43 months; a quarter within 23 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Pasritamig
Janssen Research & Development, LLC →