- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02499224
Safety and Pharmacokinetics Study of YYB101 in Advanced Solid Tumors Patients Who Are Refractory to Standard Therapy
A Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of YYB101, Hepatocyte Growth Factor (HGF)-Neutralizing Humanized Monoclonal Antibody (Mab), in Advanced Solid Tumors Patients Who Are Refractory to Standard Therapy
Descripción general del estudio
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Seoul, Corea, república de, 135-710
- Samsung Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or female patients aged 19 years or older
- Patients with pathologically or cytologically confirmed advanced solid tumor which is refractory to standard treatment or for which there is no standard therapy
- ECOG performance status ≤ 2
- Life expectancy of ≥ 12 weeks
Adequate hematologic, hepatic and renal functions as follows:
- ANC ≥ 1,500/µL (without G-CSF support within 2 weeks before IP administration)
- Platelet ≥ 100,000/µL (without transfusion within 2 weeks before IP administration)
- Hemoglobin ≥ 10.0 g/dL (without transfusion within 4 weeks before IP administration)
- Serum creatinine ≤ 1.5 mg/dL or eGRF ≥ 60 mL/min/1.73 m2
- AST and ALT ≤ 2.5 x ULN (AST and ALT ≤ 5 x ULN in the presence of liver metastasis or hepatocarcinoma)
- Total bilirubin ≤ 1.5 x ULN (with exception of the case associated with Gilbert's syndrome)
- PT and aPTT ≤ 1.5 x ULN
- UPC < 1.0 (g/g) (requiring if protein ≥ 1 positive (+) in urinalysis)
- Patients who voluntarily give written informed consent
Exclusion Criteria:
- Patients with hematologic malignancies including lymphoma
- Chemo-, radio-chemo-, biologic-, immuno- or radiotherapy for advanced solid tumor within 4 weeks (or nitrosoureas, mitomycin within 6 weeks or targeted biological antibody within 8 weeks) before IP administration
- Patients had received high-dose chemotherapy requiring hematopoietic progenitor cell support within 2 years before IP administration
- Patients with symptomatic central nervous system (CNS) metastasis (patients who are radiologically and neurologically stable condition for ≥ 4 weeks and discontinued corticosteroids at least 4 week before IP administration are able to participate in this trial.)
- History of deep vein thrombosis or pulmonary embolism within 1 year; Cytomegalovirus (CMV), Epstein-Barr virus (EBV), acute coronary syndrome (including unstable angina or myocardial infarction), or clinically significant cerebrovascular disease (including stroke) within 6 month; Major surgery requiring general anesthesia or respiratory assist within 4 weeks (or video-assisted thoracoscopic surgery or open-and-closed surgery within 2 weeks) before IP administration
- Concurrent NYHA class III or IV heart failure, uncontrolled hypertension, poorly controlled arrhythmia, other clinically significant cardiovascular abnormalities at investigator's discretion (e.g. LVEF < 50%, clinical significant abnormalities of heart wall, or cardiac muscle damage), known positive result for HIV or other uncontrolled active infection disease
- Requirement for continuous non-steroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids
- Receiving anticoagulant, history of bleeding diathesis, massive hemoptysis, gastrointestinal hemorrhage, or peptic ulcer disease (< 325 mg aspirin is acceptable)
- History of severe drug hypersensitivity or hypersensitivity to IP or similar Mab
- Pregnancy or breast-feeding
- Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 2 months after the end of treatment
- Patients who received investigational product or investigational device in other clinical trials within 3weeks prior to participation in this trial
- Patients who cannot participate in this trial at the investigator's discretion
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: YYB101
Dose-escalation cohort: YYB101 of each dose level (0.3mg/kg to 5mg/kg), IV infusion on Day 1, Day 29, and followed by every 2 weeks Dose-expansion cohort: YYB101 of MTD (or RP2D), IV infusion every 2 weeks
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Dose-escalation cohort: YYB101 of each dose level (0.3mg/kg to 5mg/kg), IV infusion on Day 1, Day 29, and followed by every 2 weeks until disease progression or unacceptable toxicity development. Dose-expansion cohort: YYB101 of MTD (or RP2D), IV infusion every 2 weeks until disease progression or unacceptable toxicity development |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Dose-escalation cohort: DLTs and MTD
Periodo de tiempo: 28 days
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28 days
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Incidence of AEs that result in discontinuation and dose reduction of YYB101
Periodo de tiempo: By 12 months after enrollment of the last subject
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By 12 months after enrollment of the last subject
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Clinical laboratory abnormalities that result in discontinuation and dose reduction of YYB101
Periodo de tiempo: By 12 months after enrollment of the last subject
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By 12 months after enrollment of the last subject
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Vital sign that result in discontinuation and dose reduction of YYB101
Periodo de tiempo: By 12 months after enrollment of the last subject
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By 12 months after enrollment of the last subject
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Anti-YYB101 antibody that result in discontinuation and dose reduction of YYB101
Periodo de tiempo: By 12 months after enrollment of the last subject
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By 12 months after enrollment of the last subject
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Area under the plasma concentration versus time curve (AUC) of YYB101
Periodo de tiempo: By 4 and 8 weeks after last administration, average 16 weeks
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By 4 and 8 weeks after last administration, average 16 weeks
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Peak Plasma Concentration (Cmax) of YYB101
Periodo de tiempo: By 4 and 8 weeks after last administration, average 16 weeks
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By 4 and 8 weeks after last administration, average 16 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Serum HGF Concentration profile according to YYB101 dosing
Periodo de tiempo: By 12 months after enrollment of the last subject
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By 12 months after enrollment of the last subject
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Tissue cMET expression level before YYB101 dosing
Periodo de tiempo: By 12 months after enrollment of the last subject
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Tissue cMET expression level and efficacy (Best overall response, Progress-free survival, Disease control rate)
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By 12 months after enrollment of the last subject
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Kim Jung Yong, MD, Ph.D, National OncoVenture/National Cancer Center
- Director de estudio: Hong SungHee, MS, National OncoVenture/National Cancer Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NOV110501-101
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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