Um estudo de JNJ-88998377 para linfoma não-Hodgkin de células B recidivante/refratário
Um estudo de fase 1, primeiro em humanos, de escalonamento de dose de JNJ-88998377 em participantes com linfoma não-Hodgkin (LNH) de células B recidivante/refratário
The main purpose of this study is to characterize safety and to determine the recommended phase 2 dose (RP2D) for JNJ-88998377 (Part A: Dose Escalation), to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Beijing, China, 100142
- Beijing Cancer Hospital
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Guangzhou, China, 510062
- Sun Yat Sen University Cancer Center
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Hangzhou, China, 310002
- The First Affiliated Hospital Zhejiang University College of Medicine
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Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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Tianjin, China, 300181
- Tianjin Medical University Cancer Institute and Hospital
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Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
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Seoul, Coréia do Sul, 06351
- Samsung Medical Center
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Bologna, Itália, 40138
- A O U Sant Orsola Malpighi
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Chūōku, Japão, 104 0045
- National Cancer Center Hospital
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Kashiwa, Japão, 277-8577
- National Cancer Center Hospital East
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Tokyo, Japão, 135 8550
- The Cancer Institute Hospital of JFCR
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Katowice, Polônia, 40 519
- Pratia Onkologia Katowice
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Kielce, Polônia, 25-734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku
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Skorzewo, Polônia, 60-185
- Aidport Sp z o o
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Taipei, Taiwan, 10043
- National Taiwan University Hospital
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Taoyuan, Taiwan, 33382
- Linkou Chang Gung Memorial Hospital
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Ankara, Turquia (Türkiye), 06200
- SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi
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Ankara, Turquia (Türkiye), 06620
- Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
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Istanbul, Turquia (Türkiye), 34010
- Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
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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:
- Participants have histologically or cytologically confirmed B-cell non-Hodgkin's Lymphoma (NHL) according to the 2022 World Health Organization (WHO) classification with relapsed or refractory disease
- Participants have measurable disease or meet all requirements for adequate response assessment as defined by the appropriate disease response criteria at screening
- Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants have a life expectancy of greater than or equal to (>=) 12 weeks
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol
Exclusion Criteria:
- Participant with active or prior history of B-cell NHL involving the central nervous system (CNS) and leptomeningeal involvement
- History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study treatment.
- For Part A and B: Participant having known allergies, hypersensitivity, or intolerance to the excipients of JNJ-88998377
- Participant had major surgery or had significant traumatic injury within 30 days before first dose of study treatment or has not recovered from surgery and must not have major surgery planned during the time the participant is receiving study treatment
- Participant received an autologous stem cell transplant less than or equal to (<=) 3 months before the first dose of study treatment
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 A: Dose Escalation
Participants will receive JNJ-88998377 at a selected starting dose. Subsequent dose levels and schedules will be selected based on the review of all available data to establish recommended Phase 2 dose (RP2D). |
JNJ-88998377 will be administered. |
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Experimental: Part B: Dose Expansion
Participants will receive JNJ-88998377 at RP2D determined in Part A. Additional expansion cohort(s) may be added with a lower RP2D(s), or different dose schedule(s) based on all available data. |
JNJ-88998377 will be administered. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Parts A and B: Number of Participants with Adverse Events (AEs)
Prazo: Upto 3 years 4 months
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. |
Upto 3 years 4 months
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Part A: Number of Participants with Dose Limiting Toxicity (DLTs)
Prazo: Cycle 1 (21 days)
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Number of participant with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological or hematological toxicity. |
Cycle 1 (21 days)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Plasma Concentration of JNJ-88998377
Prazo: Up to first 12 weeks
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Plasma concentration of oral dose of JNJ-88998377 will be assessed. |
Up to first 12 weeks
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Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377
Prazo: Up to first 12 weeks
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Area under the plasma concentration versus time curve during a dosing interval (τ) at steady-state concentration of JNJ-88998377 will be reported. |
Up to first 12 weeks
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Maximum Plasma Concentration (Cmax) of JNJ-88998377
Prazo: Up to first 12 weeks
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Cmax of JNJ-88998377 will be reported. |
Up to first 12 weeks
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Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377
Prazo: Up to first 12 weeks
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Cmin of JNJ-88998377 will be reported. |
Up to first 12 weeks
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Percentage of Participants With Overall Response (OR)
Prazo: Up to 3 years 4 months
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OR is defined as the percentage of participants who have a best response of partial response (PR) or better per investigator assessment according to disease-specific response criteria. |
Up to 3 years 4 months
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Time to Response (TTR)
Prazo: From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
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TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better per investigator assessment according to disease-specific response criteria. |
From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
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Duration of Response (DOR)
Prazo: From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)
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DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death. |
From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 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
- 88998377LYM1001
- 88998377LYM1001 (Outro identificador: Janssen Research & Development, LLC)
- 2023-509258-71-00 (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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