- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04228406
Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy Evaluation of GST-HG161
Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy Evaluation of the Selective c-MET Inhibitor GST-HG161 in Patients With Advanced or Metastatic Solid Tumors
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a phase I trial to evaluate safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy GST-HG161.
There are 7 dose cohorts, including60mg, 150mg, 300mg, 450mg, 600mg, 750mg, 900mg QD in the dose escalation stage and GST-HG161 will be administered orally to patients once daily for each dose cohort. Recommended protocal in the dose expansion stage will be determined by the results in the dose escalation stage .
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yanan Tang, MD
- Número de teléfono: +86 13585734994
- Correo electrónico: annie_tyn@163.com
Ubicaciones de estudio
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Shanghai
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Shanghai, Shanghai, Porcelana, 200135
- Reclutamiento
- Shanghai Oriental Hospital
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Contacto:
- JI LI, Professor
- Número de teléfono: +86 021-38804518
- Correo electrónico: lijin@csco.org.cn
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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:
- Voluntarily participate in this study and sign the informed consent;
- Aged >=18 years;
- Patients with advanced or metastatic solid tumors diagnosed histologically or cytologically, and no approved standard treatment regimen or no efficacy or intolerance to standard treatment regimen;
- Patients with solid tumors confirmed c-Met positive by testing. The definition of c-Met positive is: 1) IHC expression of c-Met (positive criteria : 1+ and above); 2) FISH amplification of c-Met (positive criteria: Ratio>=1.8), any positive of the above two methods can be enrolled into the group;
- The investigators evaluate according to RECIST v1.1, subjects must have at least one evaluable focus;
- Performance status 0 or 1 based on ECOG scale;
Adequate bone marrow and major organ functions:
Bone marrow: Hemoglobin>=9.0 g/dL, absolute count of neutrophils>1.5x10^9/L, platelet≥75x10^9/L; Coagulation function: Prothrombin time (PT)<=1.5 ULN, international normalized ratio (INR)<=1.5 ULN; Hepatic function: Total bilirubin<=1.5 ULN, ALT<=2.5 ULN, AST<=2.5 ULN; For patients with hepatic metastases or hepatoma, total bilirubin<=2 ULN, ALT<=5 ULN, AST<=5 ULN are allowed; Renal function: Serum creatinine<1.5 ULN, creatinine clearance rate>50mL/min; Other laboratory inspection indexes: Lipase 1.5 ULN, amylase<1.5 ULN, albumin>=28g/L;
- Expected survival time>=12 weeks;
- Fertile men and women must agree to carry out birth control with effective methods for a period of 180 days from the signing of the informed consent form until the last administration of investigational drug. Fertile women include premenopausal women and women 2 years before menopause. Fertile women must have a negative pregnancy test within 7 days (including) before the first dose of the investigational drug;
- Subjects or their legal representatives are able to communicate well with the investigators and complete the study in accordance with protocol.
Exclusion Criteria:
- Patients with clinical symptoms of brain metastasis, spinal cord compression, carcinomatous meningitis, or other evidence showing that the brain or spinal cord metastasis has not been controlled, and patients not suitable for the group judged by the investigators;
- Obvious basic cardiovascular diseases, including the following conditions: Prolonged QT/QTcF interval in baseline ECG (QTcF >480ms); Severe abnormalities in baseline ECG, including rhythm, conduction, and form. For example, complete left bundle branch block, degree III atrioventricular block, etc.; Cardiovascular abnormalities identified within 6 months, such as myocardial infraction, arrhythmia, angina, angioplasty, stent implantation, coronary artery bridging, congestive heart failure, etc.; Left ventricular ejection fraction is lower than the minimum normal value showed by cardiac ultrasound; Uncontrolled hypotension or uncontrolled hypertension;
- Digestive tract disorder that affect clinical trials, such as: Intractable hiccups, nausea, emesis, etc.; Chronic digestive diseases: Crohn's disease, ulcerative colitis, etc.; Dysphagia;
- Patients with a history of other serious underlying diseases, such as: A definite history of neurological or psychiatric disorders, including epilepsy or dementia; Patients with active hepatitis B (HBV-DNA>1000 copy number/mL), or hepatitis C virus antibody or HCV-RNA positive, or infected with human immunodeficiency virus (HIV); A history of organ transplantation; Severe infection;
- Pregnant or lactating women;
- Received chemotherapy, radiation therapy, hormonal therapy, biological therapy or other anti-tumor treatment within 4 weeks (from the last medication of mitomycin and nitrosoureas for at least 6 weeks, from the last medication of fluorouracil oral drugs, such as Tegafur, Capecitabine for at least 2 weeks), or the treatment is still within 5 half-life period;
- The adverse reactions of previous anti-tumor treatments have not recovered to CTCAE 5.0 level<=1 (except for hair loss);
- Participated in other clinical trials as a subject within 4 weeks prior to this study;
- The investigators determine ineligible to participate in the clinical trial for other reasons.
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: GST-HG161
There are 7 dose cohorts, including60mg, 150mg, 300mg, 450mg, 600mg, 750mg, 900mg QD in the dose escalation stage and GST-HG161 will be administered orally to patients once daily for each dose cohort.
Recommended dose in the dose expansion stage will be determined by the results in the dose escalation stage .
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There are 7 dose cohorts, including60mg, 150mg, 300mg, 450mg, 600mg, 750mg, 900mg QD in the dose escalation stage and GST-HG161 will be administered orally to patients once daily for each dose cohort.
Recommended dose in the dose expansion stage will be determined by the results in the dose escalation stage .
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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DLT (Dose-Limiting Toxicity)
Periodo de tiempo: Up to 27 days
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DLT was defined as one of the following adverse events (AEs) observed in 27 days: Grade 4 hematologic AE; Grade >=3 febrile neutropenia; Grade 3 thrombocytopenia with bleeding; Grade >=3 nausea, emesis, diarrhea and constipation, despite optimal treatment; Grade >=3 non-hematological AE.
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Up to 27 days
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MTD (Maximum Tolerated Dose)
Periodo de tiempo: Up to 27 days
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MTD was defined as the dose level at which 1 out of 6 subjects or no one experienced a DLT.
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Up to 27 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Area Under Curve (AUC)
Periodo de tiempo: Measured on 0,1, 2, 4, 6, 8, 12, 24 and 48 hours in single-dosing stage and pre-administration of day 6, day 13, day 20 and 0, 2, 4, 6, 8,12 and 24 hours of Day27 in the multiple-dosing stage.
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Plasma samples were collected at different points for pharmacokinetic analysis
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Measured on 0,1, 2, 4, 6, 8, 12, 24 and 48 hours in single-dosing stage and pre-administration of day 6, day 13, day 20 and 0, 2, 4, 6, 8,12 and 24 hours of Day27 in the multiple-dosing stage.
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Peak Plasma Concentration (Cmax)
Periodo de tiempo: Measured on 0,1, 2, 4, 6, 8, 12, 24 and 48 hours in single-dosing stage and pre-administration of day 6, day 13, day 20 and 0, 2, 4, 6, 8,12 and 24 hours of Day27 in the multiple-dosing stage.
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Plasma samples were collected at different points for pharmacokinetic analysis
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Measured on 0,1, 2, 4, 6, 8, 12, 24 and 48 hours in single-dosing stage and pre-administration of day 6, day 13, day 20 and 0, 2, 4, 6, 8,12 and 24 hours of Day27 in the multiple-dosing stage.
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Cl/F
Periodo de tiempo: Measured on 0,1, 2, 4, 6, 8, 12, 24 and 48 hours in single-dosing stage and pre-administration of day 6, day 13, day 20 and 0, 2, 4, 6, 8,12 and 24 hours of Day27 in the multiple-dosing stage.
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Plasma samples were collected at different points for pharmacokinetic analysis
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Measured on 0,1, 2, 4, 6, 8, 12, 24 and 48 hours in single-dosing stage and pre-administration of day 6, day 13, day 20 and 0, 2, 4, 6, 8,12 and 24 hours of Day27 in the multiple-dosing stage.
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T1/2
Periodo de tiempo: Measured on 0,1, 2, 4, 6, 8, 12, 24 and 48 hours in single-dosing stage and pre-administration of day 6, day 13, day 20 and 0, 2, 4, 6, 8,12 and 24 hours of Day27 in the multiple-dosing stage.
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Plasma samples were collected at different points for pharmacokinetic analysis
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Measured on 0,1, 2, 4, 6, 8, 12, 24 and 48 hours in single-dosing stage and pre-administration of day 6, day 13, day 20 and 0, 2, 4, 6, 8,12 and 24 hours of Day27 in the multiple-dosing stage.
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ORR
Periodo de tiempo: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 months
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Objective response rate (ORR) is defined as the proportion of subjects with complete or partial response as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 months
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PFS
Periodo de tiempo: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 months
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PFS(Progression-Free-Survival) was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever came first.
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: JI LI, PHD, Shanghai Oriental Hospital ,China
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- GST-HG161-I
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. .
Ensayos clínicos sobre Tumor solido
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Sorrento Therapeutics, Inc.RetiradoTumor solido | Tumor sólido en recaída | Tumor refractario
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Aadi Bioscience, Inc.ReclutamientoTumor sólido avanzado | Tumor | Tumor SólidoEstados Unidos
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Memorial Sloan Kettering Cancer CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterReclutamientoTumor solido | Tumor Sólido, Adulto | Tumor Sólido, No Especificado, AdultoEstados Unidos, Puerto Rico
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RemeGen Co., Ltd.TerminadoTumor sólido metastásico | Tumor sólido localmente avanzado | Tumor sólido irresecableAustralia
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Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyReclutamientoTumor Sólido, Adulto | Tumor refractarioEstados Unidos
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Impact Therapeutics, Inc.ReclutamientoTumor solido | Tumor sólido avanzadoPorcelana, Taiwán, Estados Unidos, Australia
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Partner Therapeutics, Inc.RetiradoTumor solido | Tumor Sólido, AdultoEstados Unidos
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.DesconocidoTumor sólido avanzado o tumor hematológicoPorcelana
Ensayos clínicos sobre GST-HG161
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Fujian Cosunter Pharmaceutical Co. LtdReclutamiento
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Fujian Cosunter Pharmaceutical Co. LtdDesconocido
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Fujian Akeylink Biotechnology Co., Ltd.The First Hospital of Jilin UniversityReclutamientoFarmacocinética | Efecto de los alimentos | Dosis única ascendente | Dosis máxima aplicablePorcelana
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Fujian Cosunter Pharmaceutical Co. LtdDesconocido
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Baylor College of MedicineGeorge Washington University; Children's National Research InstituteTerminadoInfección por anquilostomiasis | Enfermedad de anquilostomiasisEstados Unidos
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Baylor College of MedicineTerminadoInfección por anquilostomiasis | Enfermedad de anquilostomiasisBrasil