Uno studio su JNJ-87189401 più JNJ-78278343 per il cancro alla prostata avanzato
Uno studio di fase 1 su JNJ-87189401 (anticorpo bispecifico PSMA-CD28) combinato con JNJ-78278343 (anticorpo bispecifico KLK2-CD3) per il cancro alla prostata avanzato
The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Study Contact
- Numero di telefono: 844-434-4210
- Email: Participate-In-This-Study1@its.jnj.com
Luoghi di studio
-
-
-
Greenslopes, Australia, 4120
- Reclutamento
- Greenslopes Private Hospital
-
Melbourne, Australia, 3000
- Reclutamento
- Peter MacCallum Cancer Centre
-
-
-
-
-
Chongqing, Cina, 400030
- Reclutamento
- Chongqing University Cancer Hospital
-
Wenzhou, Cina, 325000
- Reclutamento
- The First Affiliated Hospital of Wenzhou Medical University
-
Xi'an, Cina, 710004
- Reclutamento
- The First Affiliated Hospital of Xian Jiaotong University
-
-
-
-
-
Bordeaux, Francia, 33000
- Reclutamento
- Institut Bergonie
-
Lyon, Francia, 69008
- Reclutamento
- Centre Leon Berard
-
Villejuif, Francia, 94800
- Reclutamento
- Institut Gustave Roussy
-
-
-
-
-
Tokyo, Giappone, 135 8550
- Reclutamento
- The Cancer Institute Hospital of JFCR
-
-
-
-
Colorado
-
Aurora, Colorado, Stati Uniti, 80045
- Reclutamento
- University of Colorado Anschutz Medical Campus
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30322
- Reclutamento
- Emory University Winship Cancer Institute
-
-
Minnesota
-
Minneapolis, Minnesota, Stati Uniti, 55455
- Reclutamento
- University Of Minnesota
-
-
New Jersey
-
East Brunswick, New Jersey, Stati Uniti, 08816
- Reclutamento
- START New Jersey
-
-
New York
-
New York, New York, Stati Uniti, 10032
- Reclutamento
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
-
The Bronx, New York, Stati Uniti, 10467
- Reclutamento
- Montefiore Medical Center
-
-
North Carolina
-
Charlotte, North Carolina, Stati Uniti, 28204
- Reclutamento
- Atrium Health Levine Cancer Institute
-
-
Oregon
-
Portland, Oregon, Stati Uniti, 97239
- Reclutamento
- Oregon Health And Science University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stati Uniti, 19107
- Reclutamento
- Sidney Kimmel Cancer Center - Jefferson Health
-
-
Tennessee
-
Nashville, Tennessee, Stati Uniti, 37203
- Reclutamento
- Tennessee Oncology
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- Reclutamento
- MD Anderson Cancer Center
-
San Antonio, Texas, Stati Uniti, 78229
- Reclutamento
- South Texas Accelerated Research Therapeutics, LLC (START)
-
-
Washington
-
Seattle, Washington, Stati Uniti, 98104
- Reclutamento
- Swedish Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
- Measurable or evaluable disease per PCWG3 criteria
- Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- History of an autoimmune disease within the 12 months prior to signing consent
- Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Part 1 (Dose Escalation)
Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). |
JNJ-87189401 will be administered.
Altri nomi:
JNJ-78278343 will be administered.
Altri nomi:
|
|
Sperimentale: Part 2 (Dose Expansion)
Participants with different disease settings in Parts 2A and 2B will receive JNJ-78278343+JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will receive apalutamide plus continued treatment with JNJ-87189401+JNJ-78278343 doublet. |
JNJ-87189401 will be administered.
Altri nomi:
JNJ-78278343 will be administered.
Altri nomi:
Apalutamide will be administered. |
|
Sperimentale: Part 3
Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) selected in Part 1 along with standard of care (SOC) treatment with lutetium Lu-177 vipivotide tetraxetan. Dosing of JNJ-78278343+JNJ-87189401 will be escalated sequentially, as per study evaluation team (SET) decision. |
JNJ-87189401 will be administered.
Altri nomi:
JNJ-78278343 will be administered.
Altri nomi:
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment. |
|
Sperimentale: Part 4
Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) along with JNJ-101556143. Dosing of JNJ-78278343+JNJ-87189401 along with JNJ-101556143 will be escalated sequentially to determine the RP2R of the combinations. |
JNJ-87189401 will be administered.
Altri nomi:
JNJ-78278343 will be administered.
Altri nomi:
JNJ-101556143 will be administered.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
Lasso di tempo: Up to 21 days after first combination dose of study drugs
|
DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. |
Up to 21 days after first combination dose of study drugs
|
|
Number of Participants with Adverse Events (AEs) by Severity
Lasso di tempo: Up to 4 years 8 months
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. |
Up to 4 years 8 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Serum Concentrations of JNJ-87189401 and JNJ-78278343
Lasso di tempo: Up to 4 years 8 months
|
Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343. |
Up to 4 years 8 months
|
|
Plasma Concentration of JNJ-101556143
Lasso di tempo: Up to 4 years 8 months
|
Plasma samples will be analyzed to determine concentrations of JNJ-101556143. |
Up to 4 years 8 months
|
|
Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Lasso di tempo: Up to 4 years 8 months
|
Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported. |
Up to 4 years 8 months
|
|
Objective Response Rate (ORR)
Lasso di tempo: Up to 4 years 8 months
|
ORR is defined as the proportion of participants who have a partial response (PR) or better according to response evaluation criteria in solid tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3). |
Up to 4 years 8 months
|
|
Radiographic Progression-Free Survival (rPFS)
Lasso di tempo: Up to 4 years 8 months
|
rPFS is defined time from the date of first dose of study drug until the date of objective disease progression or death, whichever comes first. |
Up to 4 years 8 months
|
|
Prostate Specific Antigen (PSA) Response Rate
Lasso di tempo: Up to 4 years 8 months
|
PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline. |
Up to 4 years 8 months
|
|
Duration of Response (DOR)
Lasso di tempo: Up to 4 years 8 months
|
DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of 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 4 years 8 months
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CR109330
- 87189401PCR1001 (Altro identificatore: Janssen Research & Development, LLC)
- 2023-504063-17-00 (Identificatore di registro: EUCT number)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .