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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07726212
A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002
A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of MC002 in Participants With Locally Advanced/Metastatic Solid Tumors
The goal of this clinical trial is to learn if ADC drug MC002 works to treat locally advanced/metastatic solid tumors in adults. It will also learn about the safety of MC002. The main questions it aims to answer are:
Does participants tolerate the drug MC002 ? What medical problems do participants have when treating with MC002? Does participants benefit from the MC002
.
Participants will:
Intravenous infusion MC002 every 3 weeks in clinical Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Medical Director
- Número de telefone: +86 13306139991
- E-mail: ke.chen@mlkbiotech.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 18 years of age and over, male or female, able to understand and willing to sign the Informed Consent Form (ICF).
- Life expectancy of 3 month or greater
- participants with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy.
- At least one measurable lesion as assessed by RECIST 1.1
- Adequate organ functions.
- ECOG Performance Status (PS) of 0-1
Exclusion Criteria:
- Pregnant or nursing females.Participants who have received chemotherapy, investigational therapy, immunotherapy, or any other antitumor active drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose.
- Known hypersensitivity to either the drug substances or inactive ingredient
- Participants who have undergone a bone marrow transplantation, solid organ transplantation, stem cell transplant.
- Participants with QTc >470 msec.
- Use of ≥10 mg of prednisone or equivalent dose of steroids per day within 3 months of administration (inhaled, intranasal, intraocular, topical and intraarticular joint injections of corticosteroids are allowed).Participants with a history of HCV infection who have not completed curative anti HCV treatment and whose HCV load is above the limit of quantification. Concurrent HCV treatment is not allowed in the trial.Live viral vaccine therapies within 4 weeks prior to the first dose of study drug.
- Participants who have received treatment with any herbal or alternative therapies within 7 days prior to the first dose of the study drug.
- Male and female participants of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: dose escalation
MC002 dose escalation
|
MC002 is a recombinant antibody-drug conjugate targeting the oncofetal antigen.A complete treatment cycle is defined as 21 calendar days.
MC002 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To assess the Number of patients with Adverse Events (AE)
Prazo: From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up
|
Any medical event in a participant which may or may not have a causal relationship with this treatment.
|
From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up
|
|
Determination of MTD or RP2D
Prazo: From enrollment until 28 days after last study drug
|
Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of MC002
|
From enrollment until 28 days after last study drug
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Maximum concentration (Cmax)
Prazo: From enrollment until 28 days after last study drug
|
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
|
From enrollment until 28 days after last study drug
|
|
ADA
Prazo: From enrollment until 28 after last study drug
|
Incidence, onset time, and titer of ADAs against MC002
|
From enrollment until 28 after last study drug
|
|
The time taken to reach the maximum concentration (Tmax)
Prazo: From enrollment until 28 days after last study drug
|
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
|
From enrollment until 28 days after last study drug
|
|
Area Under Curve (AUC)
Prazo: From enrollment until 28 days after last study drug
|
PK endpoint
|
From enrollment until 28 days after last study drug
|
|
Half life (T1/2)
Prazo: From enrollment until 28 days after last study drug
|
Half life (T1/2)
|
From enrollment until 28 days after last study drug
|
|
Trough concentration (Cmin)
Prazo: From enrollment until 28 days after last study drug
|
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmin will be derived)
|
From enrollment until 28 days after last study drug
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall response rate (ORR)
Prazo: From enrollment until 28 days after last study drug.
|
the proportion/percentage of participants with best overall response of CR or PR。
|
From enrollment until 28 days after last study drug.
|
|
progression-free survival (PFS)
Prazo: From enrollment until 28 days after last study drug.
|
assessed per RECISTv1.1
|
From enrollment until 28 days after last study drug.
|
Colaboradores e Investigadores
Patrocinador
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MC002 FIH Study
- Sponsor (Número de outro subsídio/financiamento: Sponsor)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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