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Not yet recruiting NCT07746713

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

Phase I Interventional Prostatic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JNJ-98768111.
Who it may be relevant to
Registry conditions: Prostatic Neoplasms. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug JNJ-98768111
    JNJ-98768111 will be administered intravenously.

Primary outcome measures

  • 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)]
Secondary outcome measures (10)
  • Maximum Observed Concentration (Cmax) of JNJ-98768111 [Time frame: Up to approximately 2 years 7 months]
  • Trough Concentration (Ctrough) of JNJ-98768111 [Time frame: Up to approximately 2 years 7 months]
  • Time to Maximum Observed Concentration (Tmax) of JNJ-98768111 [Time frame: 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 [Time frame: Up to approximately 2 years 7 months]
  • Accumulation Ratio of JNJ-98768111 [Time frame: Up to approximately 2 years 7 months]
  • Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-98768111 [Time frame: Up to approximately 2 years 7 months]
  • Objective Response Rate (ORR) [Time frame: Up to approximately 2 years 7 months]
  • Radiographic Progression-Free Survival (rPFS) [Time frame: Up to approximately 2 years 7 months]
  • Prostate-Specific Antigen (PSA) Response [Time frame: Up to approximately 2 years 7 months]
  • Duration of Response (DOR) [Time frame: Up to approximately 2 years 7 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07746713 · 98768111PCR1001 · 2026-525894-37-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗