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

27. august 2026 opdateret af: Janssen Research & Development, LLC

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Florida
      • Sarasota, Florida, Forenede Stater, 34232
        • Rekruttering
        • Florida Cancer Specialists & Research Institute
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49546
        • Rekruttering
        • START MidWest
    • Utah
      • West Valley City, Utah, Forenede Stater, 84119
        • Rekruttering
        • START Mountain Region

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: JNJ-98768111
JNJ-98768111 will be administered intravenously.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants with Adverse Events (AEs)
Tidsramme: 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.
Up to approximately 2 years 7 months
Part 1: Number of Participants with Dose-Limiting Toxicities (DLT)
Tidsramme: 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.
From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Observed Concentration (Cmax) of JNJ-98768111
Tidsramme: Up to approximately 2 years 7 months
Cmax of JNJ-98768111 will be reported.
Up to approximately 2 years 7 months
Trough Concentration (Ctrough) of JNJ-98768111
Tidsramme: Up to approximately 2 years 7 months
Ctrough of JNJ-98768111 will be reported.
Up to approximately 2 years 7 months
Time to Maximum Observed Concentration (Tmax) of JNJ-98768111
Tidsramme: Up to approximately 2 years 7 months
Tmax of JNJ-98768111 will be reported.
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
Tidsramme: Up to approximately 2 years 7 months
AUC0-tau of JNJ-98768111 will be reported.
Up to approximately 2 years 7 months
Accumulation Ratio of JNJ-98768111
Tidsramme: 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.
Up to approximately 2 years 7 months
Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-98768111
Tidsramme: Up to approximately 2 years 7 months
Number of participants with antibodies to JNJ-98768111 will be reported.
Up to approximately 2 years 7 months
Objective Response Rate (ORR)
Tidsramme: 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).
Up to approximately 2 years 7 months
Radiographic Progression-Free Survival (rPFS)
Tidsramme: 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.
Up to approximately 2 years 7 months
Prostate-Specific Antigen (PSA) Response
Tidsramme: 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.
Up to approximately 2 years 7 months
Duration of Response (DOR)
Tidsramme: 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.
Up to approximately 2 years 7 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Efterforskere

  • Studieleder: Janssen Research & Development LLC Clinical Trial, Janssen Research & Development, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. august 2026

Primær færdiggørelse (Anslået)

16. marts 2029

Studieafslutning (Anslået)

16. marts 2029

Datoer for studieregistrering

Først indsendt

31. juli 2026

Først indsendt, der opfyldte QC-kriterier

31. juli 2026

Først opslået (Faktiske)

5. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 98768111PCR1001
  • 2026-525894-37-00 (Registry Identifier: EUCT number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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