A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer

NCT07746713 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 98768111PCR10012026-525894-37-00
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 5

Brief 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).

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)

Secondary Outcomes (10)

• Maximum Observed Concentration (Cmax) of JNJ-98768111

  Up to approximately 2 years 7 months

• Trough Concentration (Ctrough) of JNJ-98768111

  Up to approximately 2 years 7 months

• Time to Maximum Observed Concentration (Tmax) of JNJ-98768111

  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

  Up to approximately 2 years 7 months

• Accumulation Ratio of JNJ-98768111

  Up to approximately 2 years 7 months

Study Arms (1)

JNJ-98768111

EXPERIMENTAL

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

Interventions

JNJ-98768111 DRUG

JNJ-98768111 will be administered intravenously.

JNJ-98768111

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active central nervous system (CNS) involvement
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (5)

Florida Cancer Specialists & Research Institute

Sarasota, Florida, 34232, United States

RECRUITING

Start Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: August 5, 2026
• Primary Completion (Estimated): March 16, 2029
• Study Completion (Estimated): March 16, 2029
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (3); IL (2)