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

Study Identifier:
98768111PCR1001
CT.gov Identifier:
NCT07746713
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2026-525894-37-00
Study Contact Information:
N/A
Will Be Recruiting

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Study 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).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: JNJ-98768111
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Drug: 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: Drug: JNJ-98768111
Drug: JNJ-98768111 will be administered intravenously.
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Emerson Lim
Status
Will Be Recruiting
Condition(s) Treated at Site
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Jose Pacheco
Status
Will Be Recruiting
Condition(s) Treated at Site