Testing JNJ-98768111, an antibody drug, in advanced prostate cancer
Tests the safety and dose of JNJ-98768111 in adults with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
Key facts
- Where
- Madrid, SpainSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
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 that has spread and has grown again after their latest treatment, to test how safe JNJ-98768111 is.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate cancer (adenocarcinoma; small cell or neuroendocrine features are allowed) that has spread, can be seen or measured on scans, and has grown again after the most recent treatment. Performance status (ECOG) must be 0 or 1.
- Earlier treatment
- At least 1 earlier androgen receptor-targeted therapy. Surgical removal of the testicles or ongoing hormone therapy (ADT with a GnRH analog) with castrate testosterone levels, continued during the trial.
- Biomarker or test result
- Blood PSA level of 2 ng/mL or higher (>= 2 ng/mL). Castrate level of testosterone in the blood.
Main reasons for not taking part
- Active cancer in the brain or spinal cord (CNS)
- Side effects from earlier cancer treatment not back to Grade 1 or baseline
- External beam radiation to soft tissue lesions within 14 days before the trial starts
- Significant heart or blood vessel disease within the last 6 months
- Past solid organ or bone marrow transplant
Read by machine on 13 November 2026.
Where in Spain
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainNot yet recruiting
- Hospital Universitario HM SanchinarroMadrid, SpainNot yet recruiting
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 doctorTrial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07746713EU 2026-525894-37-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
A Phase 1 Trial of JNJ-98768111, an Antibody Drug Conjugate (ADC) Targeting Human Kallikrein-2 (KLK2) for Advanced Prostate Cancer
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).
Inclusion: a. Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine features is permitted. b. Measurable or evaluable disease (metastatic prostate cancer) based on computed tomography (CT), magnetic resonance imaging (MRI), or bone scan. Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy. c. Serum prostate-specific antigen (PSA) value greater than or equal to (>=) 2 nanograms per milliliters (ng/mL). d. Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose of trial drug and must continue this therapy throughout the treatment phase; e. Castrate levels of serum testosterone as defined in the protocol, prior to the first dose of trial intervention; f. Progressive metastatic disease following their most recent line of therapy. Disease progression will be defined by at least one of the following: PSA progression, radiographic progression according to response evaluation criteria in solid tumors (RECIST v1.1), or progressive bone disease according to prostate cancer working group 3 (PCWG3) criteria; Eastern cooperative oncology group (ECOG) performance status of 0 or 1; Agree to all of the following during the trial and for 6 months after the last dose of trial drug: a. Use a highly effective method of contraception; b. Wear a condom when engaging in any activity that allows for passage of ejaculate to another person; c. Not to donate sperm or freeze for future use for the purpose of reproduction; d. Not plan to father a child. In addition, the participant should be advised of the benefit for a female partner to use a highly effective method of contraception; Sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the trial and is willing to participate in the trial.
Exclusion: Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels; External beam radiation therapy to soft tissue lesions within 14 days prior to start of trial intervention; History of clinically significant cardiovascular disease within 6 months prior to signing informed consent; History of solid organ or bone marrow transplantation; Active central nervous system (CNS) involvement.