A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer (NCT07746713) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
100 participantsStarted 2026-08-17
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 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
* 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 p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial of JNJ-98768111, which means it's primarily focused on finding a safe dose rather than proving it works, how does that affect the balance of potential risk versus benefit for my situation?
2The trial is listed as 'not yet recruiting' — given where my cancer is right now, is it worth waiting for this study to open, or should we be moving forward with a treatment option that's available today?
3One of the main things this trial is measuring is dose-limiting toxicities, which are side effects serious enough to cap the dose — what kinds of side effects should I be prepared to watch for with a new drug like JNJ-98768111, and how would those be managed?
4My prostate cancer is described as 'advanced' — can you help me understand whether the stage and treatment history I have would likely be relevant to how investigators are thinking about who they'll enroll in this study?
5Are there existing approved treatments for advanced prostate cancer that I should consider first before looking at an early-phase trial like this, and how would participating in this study affect my ability to access those options later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Adverse Events (AEs)
Timeframe: Up to approximately 2 years 7 months
2
Part 1: Number of Participants with Dose-Limiting Toxicities (DLT)
Timeframe: From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)