Um estudo de JNJ-87189401 Plus JNJ-78278343 para câncer de próstata avançado
Um estudo de fase 1 de JNJ-87189401 (anticorpo biespecífico PSMA-CD28) combinado com JNJ-78278343 (anticorpo biespecífico KLK2-CD3) para câncer de próstata avançado
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Study Contact
- Número de telefone: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Locais de estudo
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Greenslopes, Austrália, 4120
- Recrutamento
- Greenslopes Private Hospital
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Melbourne, Austrália, 3000
- Recrutamento
- Peter MacCallum Cancer Centre
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Chongqing, China, 400030
- Recrutamento
- Chongqing University Cancer Hospital
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Wenzhou, China, 325000
- Recrutamento
- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, China, 710004
- Recrutamento
- The First Affiliated Hospital of Xian Jiaotong University
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Recrutamento
- University of Colorado Anschutz Medical Campus
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Recrutamento
- Emory University Winship Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- Recrutamento
- University Of Minnesota
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New Jersey
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East Brunswick, New Jersey, Estados Unidos, 08816
- Recrutamento
- START New Jersey
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New York
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New York, New York, Estados Unidos, 10032
- Recrutamento
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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The Bronx, New York, Estados Unidos, 10467
- Recrutamento
- Montefiore Medical Center
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Recrutamento
- Atrium Health Levine Cancer Institute
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Recrutamento
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Recrutamento
- Sidney Kimmel Cancer Center - Jefferson Health
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Recrutamento
- Tennessee Oncology
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Texas
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Houston, Texas, Estados Unidos, 77030
- Recrutamento
- MD Anderson Cancer Center
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San Antonio, Texas, Estados Unidos, 78229
- Recrutamento
- South Texas Accelerated Research Therapeutics, LLC (START)
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Recrutamento
- Swedish Medical Center
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Bordeaux, França, 33000
- Recrutamento
- Institut Bergonie
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Lyon, França, 69008
- Recrutamento
- Centre Leon Berard
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Villejuif, França, 94800
- Recrutamento
- Institut Gustave Roussy
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Tokyo, Japão, 135 8550
- Recrutamento
- The Cancer Institute Hospital of JFCR
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
Outros nomes:
JNJ-78278343 will be administered.
Outros nomes:
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Experimental: 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.
Outros nomes:
JNJ-78278343 will be administered.
Outros nomes:
Apalutamide will be administered. |
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Experimental: 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.
Outros nomes:
JNJ-78278343 will be administered.
Outros nomes:
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment. |
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Experimental: 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.
Outros nomes:
JNJ-78278343 will be administered.
Outros nomes:
JNJ-101556143 will be administered.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Serum Concentrations of JNJ-87189401 and JNJ-78278343
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CR109330
- 87189401PCR1001 (Outro identificador: Janssen Research & Development, LLC)
- 2023-504063-17-00 (Identificador de registro: EUCT number)
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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
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