A Phase 1 interventional study of JNJ-98768111 in Prostatic Neoplasms, sponsored by Janssen Research & Development, LLC. Recruiting at 6 sites in 2 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 23rd largest by planned enrollment of the 68 interventional ones that give a count, is one of 4 that started in 2026, is one of 27 in phase 1, reaches primary completion later than 20 of the 22 other live ones, and was the 86th registered.
7,046 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, United Kingdom
Ages 18+
Janssen Cilag S.A.S. · Sites in France
Ages 18+ · Men only
Janssen Research & Development, LLC · Sites in United States, United Kingdom
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 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 160 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.
This tab as a report to print or save as PDF → With an account.
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, 136 (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 Part 1 of this study is to find out how safe JNJ-98768111 is and the most suitable dose (recommended phase 2 dose [RP2D]) regimen(s) of JNJ-98768111. The purpose of Part 2 of this study is to find out how safe JNJ-98768111 is at the RP2D regimen(s) in participants with advanced prostate cancer (cancer of the prostate, a male reproductive gland found below the bladder, which has spread extensively to other parts of the body).
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Participants in Part 1 of the study will receive escalating doses of JNJ-98768111 to identify the putative recommended phase 2 dose (pRP2D) regimen(s). Participants in Part 2 of the study will receive JNJ-98768111 at the pRP2D regimen(s) determined in Part 1.
Drug: JNJ-98768111
JNJ-98768111 will be administered intravenously.
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment.
Time frame: Up to approximately 2 years 7 months
Part 1: Number of Participants with Dose-Limiting Toxicities (DLT)
High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT. Other DLT criteria includes any related toxicity resulting in permanent treatment discontinuation or a delay in dose administration greater than (\>)14 days and any death not clearly due to the underlying disease or non-trial intervention-related causes.
Time frame: From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)
Maximum Observed Concentration (Cmax) of JNJ-98768111
Cmax of JNJ-98768111 will be reported.
Time frame: Up to approximately 2 years 7 months
Trough Concentration (Ctrough) of JNJ-98768111
Ctrough of JNJ-98768111 will be reported.
Time frame: Up to approximately 2 years 7 months
Time to Maximum Observed Concentration (Tmax) of JNJ-98768111
Tmax of JNJ-98768111 will be reported.
Time frame: Up to approximately 2 years 7 months
Area Under the Concentration-Time Curve from Time 0 to End of Dosing Interval (AUC [0-tau]) of JNJ-98768111
AUC0-tau of JNJ-98768111 will be reported.
Time frame: Up to approximately 2 years 7 months
Accumulation Ratio of JNJ-98768111
Accumulation Ratio (RA) is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC \[0-24\]) value at steady state divided by AUC (0-24) value after first dose.
Time frame: Up to approximately 2 years 7 months
Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-98768111
Number of participants with antibodies to JNJ-98768111 will be reported.
Time frame: Up to approximately 2 years 7 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with measurable disease who have a partial response (PR) or better without evidence of bone progression according to prostate cancer working group 3 (PCWG3).
Time frame: Up to approximately 2 years 7 months
Radiographic Progression-Free Survival (rPFS)
rPFS is defined as the time from the date of first dose until the date of objective disease progression or death, whichever comes first.
Time frame: Up to approximately 2 years 7 months
Prostate-Specific Antigen (PSA) Response
PSA response rate is defined as the percentage of participants with a decline in PSA of 50% or more from baseline which is sustained for greater than or equal to (\>=) 3 weeks.
Time frame: Up to approximately 2 years 7 months
Duration of Response (DOR)
DOR will be calculated among responders (PR or better) from the date of initial documentation of a 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 approximately 2 years 7 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 ↗ · www.jnj.com
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Mar 2029, 31 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 31 months is below 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 ↗
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