Recruiting
Phase 1

JNJ-98768111

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07746713

Conditions

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-98768111

Study Details

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

Study ID

NCT07746713

Start date

Aug 5, 2026

Status verified date

Aug, 2026

Completion date

Mar 16, 2029

Anticipated

Primary completion date

Mar 16, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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; 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 criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JNJ-98768111

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.

Interventions

JNJ-98768111

JNJ-98768111 will be administered intravenously.

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 2 years 7 months ]
  • Part 1: Number of Participants with Dose-Limiting Toxicities (DLT) [ 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) ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

Florida Cancer Specialists & Research Institute

Recruiting

Sarasota, Florida, United States, 34232

Start Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-31.