- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT06799286
Um estudo para avaliar a segurança, tolerabilidade, farmacocinética e eficácia preliminar do BMS-986489 em participantes chineses com câncer de pulmão de pequenas células pequenas recidivadas/refratárias
Um estudo de fase 1 aberto, de braço único, multicêntrico, para avaliar a segurança, a tolerabilidade, a farmacocinética e a eficácia preliminar de BMS-986489 (BMS-986012 + combinação de dose fixa de nivolumab) em participantes chineses com recaída/refratária pequena célula Lung Lung. Câncer
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of BMS-986489 in Chinese participants with R/R SCLC (Relapsed/Refractory Small Cell Lung Cancer).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Shanghai, China, 200120
- Local Institution - 0002
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Local Institution - 0004
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Shandong
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Jinan, Shandong, China, 250117
- Local Institution - 0003
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Linyi, Shandong, China, 276001
- Local Institution - 0001
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Local Institution - 0005
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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 must have histologically or cytologically documented SCLC (small cell lung cancer). Participants with either limited or extensive disease stage at the initial diagnosis, who have received at least one prior line of systemic therapy, are eligible.
i) For initial limited stage (LS) SCLC:.
A. Those who progressed or recurred after more than 6 months treatment-free interval following treatment of curative surgical resection, systemic therapy, or radiotherapy, and subsequently received at least one line of systemic therapy to treat the recurrence or progression, and then progressed, or were intolerant to the prior systemic therapy per the assessment of investigators, these participants will be eligible, or
B. Who progressed or recurred within 6 months after treatment of curative surgical resection, systemic therapy, or radiotherapy, no matter if these participants have received subsequent systemic therapy, these participants will be eligible.
ii) For initial extensive stage (ES) SCLC, participants must have received at least one line of platinum-based systemic therapy (with/without immunotherapy), and then progressed, or been intolerant to the prior systemic therapy per the assessment of investigators.
A. Note: 1) For ES-SCLC with only one line of platinum-based regimen as well as chemotherapy-free interval is more than 6months when progression, only when participants refuse or are ineligible for re-treatment with platinum-based doublet per the assessment of investigators, these participants will be eligible. 2) If participants receive re-treatment with a platinum-based regimen, it is considered a second line of therapy.
- Participants must have a life expectancy of ≥12 weeks.
- Participants must have at least 1 measurable lesion outside the central nervous system (CNS) by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Exclusion Criteria:
- Untreated symptomatic CNS metastases.
- Leptomeningeal disease.
- Pleural effusion which cannot be controlled with appropriate interventions.
- Malignancy-related superior vena cava syndrome.
- Participants with an active, known or suspected, autoimmune disease.
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to first study treatment.
- Unresolved toxicity from prior anti-tumor therapy.
- Prior treatment with an anti-fuc-GM1 therapy or any other drug specifically targeting fuc-GM1.
- Other protocol-defined inclusion/exclusion criteria apply.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: BMS-986489
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Specified dose on specified days |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Number of participants with adverse events (AEs)
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of participants with Serious AEs (SAEs)
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of participants with AEs leading to discontinuation of study treatment
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of participants with select AEs
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of participants with immune-mediated AEs (IMAEs)
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of deaths
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of participants with laboratory abnormalities
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Maximum observed concentration (Cmax) for BMS-986012
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Time of maximum observed concentration (Tmax) for BMS-986012
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Trough observed plasma concentration (Ctrough) for BMS-986012
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Concentration at the end of a dosing interval (Ctau) for BMS-986012
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Total body clearance (CLT) for BMS-986012
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Observed concentration at end of infusion (Ceoi) for BMS-986012
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants with anti-drug antibodies (ADAs) to BMS-986012
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
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Number of participants with ADAs to nivolumab
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
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Ctrough for nivolumab
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
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|
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Ceoi for nivolumab
Prazo: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
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Overall Response (OR)
Prazo: Up to 19 months after last participant's first treatment
|
Achievement of best response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, assessed by the investigator. |
Up to 19 months after last participant's first treatment
|
|
Disease Control (DC)
Prazo: Up to 19 months after last participant's first treatment
|
Achievement of best response of CR or PR or stable disease (SD) using RECIST v1.1 criteria, assessed by the investigator. |
Up to 19 months after last participant's first treatment
|
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Duration of Response (DOR)
Prazo: Up to 19 months after last participant's first treatment
|
Time from first response (CR or PR) to first documented disease progression by investigator or death, whichever occurs first. For participants who did not have an event, the DOR will be censored on the date of their last tumor assessment. |
Up to 19 months after last participant's first treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Bristol-Myers Squibb, Bristol-Myers Squibb
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CA245-0002
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Prazo de Compartilhamento de IPD
See Plan Description
Critérios de acesso de compartilhamento IPD
See Plan Description
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
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