Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

27. august 2026 oppdatert av: 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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: JNJ-98768111
JNJ-98768111 will be administered intravenously.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Research & Development, LLC

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. august 2026

Primær fullføring (Antatt)

16. mars 2029

Studiet fullført (Antatt)

16. mars 2029

Datoer for studieregistrering

Først innsendt

31. juli 2026

Først innsendt som oppfylte QC-kriteriene

31. juli 2026

Først lagt ut (Faktiske)

5. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere