Phase 1 Study of MST-168 in Participants With Advanced Solid Malignant Tumors
A Phase 1, Multiregional, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MST-168, in Participants With Advanced Solid Malignant Tumors
A Phase 1, multiregional, open-label study of MST-168 in participants with target-driven advanced solid tumors.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy of MST-168 in participants with target-driven advanced solid tumors. MST-168 is an investigational ADC.
Visão geral do estudo
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Changlong Liu
- Número de telefone: +86-15810213012
- E-mail: changlong.liu@mabsoftbio.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Participants are eligible to be included in the study only if all of the following criteria apply:
I1. Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
I2. Is at least 18 years of age at the time of signing the ICF.
I3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
I4. Life expectancy ≥ 12 weeks.
I5. Has adequate organ function.
I6. Pregnancy and Contraception: Female participants agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment. Male participants with partners of childbearing potential and female participants of childbearing potential are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from beginning of the study screening until 6 months after receiving the last treatment of MST-168.
I7. Has a pathologically documented advanced/unresectable or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Exclusion Criteria:
- Participants are excluded from the study if any of the following criteria apply:
E1. Has untreated brain or CNS metastases or brain/CNS metastases that have progressed [e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases]. Participants with previously unstable brain or CNS metastases.
E2. Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
E3. Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
E4. Has known sensitivity to study intervention components or excipients.
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: MST-168 initial dose level treatment Cohort
MST-168 initial dose level
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MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
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Experimental: MST-168 dose level 2 treatment Cohort
MST-168 dose level 2
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MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
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Experimental: MST-168 dose level 3 treatment Cohort
MST-168 dose level 3
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
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Experimental: MST-168 dose level 4 treatment Cohort
MST-168 dose level 4
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
Experimental: MST-168 dose level 5 treatment Cohort
MST-168 dose level 5
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
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|
Experimental: MST-168 dose level 6 treatment Cohort
MST-168 dose level 6, if needed
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Incidence of dose-limiting toxicities (DLT)
Prazo: Day 1 - Day 28
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Day 1 - Day 28
|
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Incidence and severity of AEs, clinically significant changes from Baseline (pre-dose on D1) through to the EOT in vital signs, laboratory tests, physical examinations, 12-lead ECG, and ECHO/MUGA.
Prazo: Through study completion, up to 25 months
|
Through study completion, up to 25 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Tmax
Prazo: Day 1 to Day 8
|
Day 1 to Day 8
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PK parameters for MST-168, total anti-drug antibody and free payload: Cmax
Prazo: Day 1 to Day 8
|
Day 1 to Day 8
|
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PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t
Prazo: Day 1 to Day 8
|
Day 1 to Day 8
|
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PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞
Prazo: Day 1 to Day 8
|
Day 1 to Day 8
|
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PK parameters for MST-168, total anti-drug antibody and free payload: t1/2
Prazo: Day 1 to Day 8
|
Day 1 to Day 8
|
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PK parameters for MST-168, total anti-drug antibody and free payload: CL
Prazo: Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Vss
Prazo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: AUCss
Prazo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Css,max
Prazo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Css,min
Prazo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Frequencies of ADAs and neutralizing antibodies specific to MST-168.
Prazo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Biomarkers: cytokines/chemokines and immune cell phenotypes
Prazo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Objective response rate (ORR) based on RECIST v1.1.
Prazo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Duration of response (DoR) based on RECIST v1.1.
Prazo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Progression-free survival (PFS) based on RECIST v1.1.
Prazo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Disease control rate (DCR) based on RECIST v1.1.
Prazo: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
Palavras-chave
Outros números de identificação do estudo
- MST-168-101
Plano para dados de participantes individuais (IPD)
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