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NCT Number: NCT07746713

A Study of JNJ-98768111 in Participants With 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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

JNJ-98768111

Drug

JNJ-98768111 will be administered intravenously.

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 2 years 7 months

    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.

  2. 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)

    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.

Secondary outcomes

  1. Maximum Observed Concentration (Cmax) of JNJ-98768111

    Time frame: Up to approximately 2 years 7 months

    Cmax of JNJ-98768111 will be reported.

  2. Trough Concentration (Ctrough) of JNJ-98768111

    Time frame: Up to approximately 2 years 7 months

    Ctrough of JNJ-98768111 will be reported.

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

    Time frame: Up to approximately 2 years 7 months

    Tmax of JNJ-98768111 will be reported.

  4. Area Under the Concentration-Time Curve from Time 0 to End of Dosing Interval (AUC [0-tau]) of JNJ-98768111

    Time frame: Up to approximately 2 years 7 months

    AUC0-tau of JNJ-98768111 will be reported.

  5. Accumulation Ratio of JNJ-98768111

    Time frame: Up to approximately 2 years 7 months

    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.

  6. Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-98768111

    Time frame: Up to approximately 2 years 7 months

    Number of participants with antibodies to JNJ-98768111 will be reported.

  7. Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years 7 months

    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).

  8. Radiographic Progression-Free Survival (rPFS)

    Time frame: Up to approximately 2 years 7 months

    rPFS is defined as the time from the date of first dose until the date of objective disease progression or death, whichever comes first.

  9. Prostate-Specific Antigen (PSA) Response

    Time frame: Up to approximately 2 years 7 months

    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.

  10. Duration of Response (DOR)

    Time frame: Up to approximately 2 years 7 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1 Trial of JNJ-98768111, an Antibody Drug Conjugate (ADC) Targeting Human Kallikrein-2 (KLK2) for Advanced Prostate Cancer

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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