Une étude de JNJ-87189401 plus JNJ-78278343 pour le cancer avancé de la prostate
Une étude de phase 1 sur le JNJ-87189401 (anticorps bispécifique PSMA-CD28) associé au JNJ-78278343 (anticorps bispécifique KLK2-CD3) pour le cancer de la prostate avancé
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Study Contact
- Numéro de téléphone: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Lieux d'étude
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Greenslopes, Australie, 4120
- Recrutement
- Greenslopes Private Hospital
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Melbourne, Australie, 3000
- Recrutement
- Peter MacCallum Cancer Centre
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Chongqing, Chine, 400030
- Recrutement
- Chongqing University Cancer Hospital
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Wenzhou, Chine, 325000
- Recrutement
- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, Chine, 710004
- Recrutement
- The First Affiliated Hospital of Xian Jiaotong University
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Bordeaux, France, 33000
- Recrutement
- Institut Bergonie
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Lyon, France, 69008
- Recrutement
- Centre Leon Berard
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Villejuif, France, 94800
- Recrutement
- Institut Gustave Roussy
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Tokyo, Japon, 135 8550
- Recrutement
- The Cancer Institute Hospital of JFCR
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Colorado
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Aurora, Colorado, États-Unis, 80045
- Recrutement
- University of Colorado Anschutz Medical Campus
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Recrutement
- Emory University Winship Cancer Institute
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- Recrutement
- University Of Minnesota
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New Jersey
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East Brunswick, New Jersey, États-Unis, 08816
- Recrutement
- START New Jersey
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New York
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New York, New York, États-Unis, 10032
- Recrutement
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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The Bronx, New York, États-Unis, 10467
- Recrutement
- Montefiore Medical Center
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North Carolina
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Charlotte, North Carolina, États-Unis, 28204
- Recrutement
- Atrium Health Levine Cancer Institute
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Oregon
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Portland, Oregon, États-Unis, 97239
- Recrutement
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Recrutement
- Sidney Kimmel Cancer Center - Jefferson Health
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Tennessee
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- Tennessee Oncology
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Texas
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Houston, Texas, États-Unis, 77030
- Recrutement
- MD Anderson Cancer Center
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San Antonio, Texas, États-Unis, 78229
- Recrutement
- South Texas Accelerated Research Therapeutics, LLC (START)
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Washington
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Seattle, Washington, États-Unis, 98104
- Recrutement
- Swedish Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
Autres noms:
JNJ-78278343 will be administered.
Autres noms:
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Expérimental: 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.
Autres noms:
JNJ-78278343 will be administered.
Autres noms:
Apalutamide will be administered. |
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Expérimental: 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.
Autres noms:
JNJ-78278343 will be administered.
Autres noms:
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment. |
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Expérimental: 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.
Autres noms:
JNJ-78278343 will be administered.
Autres noms:
JNJ-101556143 will be administered.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
Délai: Up to 21 days after first combination dose of study drugs
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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
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Number of Participants with Adverse Events (AEs) by Severity
Délai: Up to 4 years 8 months
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Serum Concentrations of JNJ-87189401 and JNJ-78278343
Délai: Up to 4 years 8 months
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Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343. |
Up to 4 years 8 months
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Plasma Concentration of JNJ-101556143
Délai: Up to 4 years 8 months
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Plasma samples will be analyzed to determine concentrations of JNJ-101556143. |
Up to 4 years 8 months
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Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Délai: Up to 4 years 8 months
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Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported. |
Up to 4 years 8 months
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Objective Response Rate (ORR)
Délai: Up to 4 years 8 months
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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
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Radiographic Progression-Free Survival (rPFS)
Délai: Up to 4 years 8 months
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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
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Prostate Specific Antigen (PSA) Response Rate
Délai: Up to 4 years 8 months
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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
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Duration of Response (DOR)
Délai: Up to 4 years 8 months
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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
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR109330
- 87189401PCR1001 (Autre identifiant: Janssen Research & Development, LLC)
- 2023-504063-17-00 (Identificateur de registre: EUCT number)
- 2023 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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
Informations sur les médicaments et les dispositifs, documents d'étude
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