- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07746713
A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
27 augusti 2026 uppdaterad 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).
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studieorter
-
-
Florida
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Sarasota, Florida, Förenta staterna, 34232
- Rekrytering
- Florida Cancer Specialists & Research Institute
-
-
Michigan
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Grand Rapids, Michigan, Förenta staterna, 49546
- Rekrytering
- START MidWest
-
-
Utah
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West Valley City, Utah, Förenta staterna, 84119
- Rekrytering
- START Mountain Region
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
JNJ-98768111 will be administered intravenously.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants with Adverse Events (AEs)
Tidsram: 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)
Tidsram: 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.
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From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maximum Observed Concentration (Cmax) of JNJ-98768111
Tidsram: Up to approximately 2 years 7 months
|
Cmax of JNJ-98768111 will be reported.
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Up to approximately 2 years 7 months
|
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Trough Concentration (Ctrough) of JNJ-98768111
Tidsram: Up to approximately 2 years 7 months
|
Ctrough of JNJ-98768111 will be reported.
|
Up to approximately 2 years 7 months
|
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Time to Maximum Observed Concentration (Tmax) of JNJ-98768111
Tidsram: 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
Tidsram: Up to approximately 2 years 7 months
|
AUC0-tau of JNJ-98768111 will be reported.
|
Up to approximately 2 years 7 months
|
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Accumulation Ratio of JNJ-98768111
Tidsram: 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
|
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Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-98768111
Tidsram: 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)
Tidsram: 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).
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Up to approximately 2 years 7 months
|
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Radiographic Progression-Free Survival (rPFS)
Tidsram: Up to approximately 2 years 7 months
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rPFS is defined as the time from the date of first dose until the date of objective disease progression or death, whichever comes first.
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Up to approximately 2 years 7 months
|
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Prostate-Specific Antigen (PSA) Response
Tidsram: 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.
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Up to approximately 2 years 7 months
|
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Duration of Response (DOR)
Tidsram: 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.
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Up to approximately 2 years 7 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Janssen Research & Development LLC Clinical Trial, Janssen Research & Development, LLC
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
5 augusti 2026
Primärt slutförande (Beräknad)
16 mars 2029
Avslutad studie (Beräknad)
16 mars 2029
Studieregistreringsdatum
Först inskickad
31 juli 2026
Först inskickad som uppfyllde QC-kriterierna
31 juli 2026
Första postat (Faktisk)
5 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 98768111PCR1001
- 2026-525894-37-00 (Registeridentifierare: EUCT number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .