- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04164615
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection
A Randomized, Double-blind, Multi-center Phase Ⅲ Clinical Study to Evaluate the Recombinant Anti-HER2 Humanized Monoclonal Antibody or Placebo in Combination With Capecitabine for the Treatment of HER-2-positive Advanced Breast Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100071
- Reclutamiento
- People's Liberation Army General Hospital The Fifth Medical Center
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Investigador principal:
- Ze Fei Jiang, Ph.D
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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
- Aged 18 to 70 years;
Pathologically confirmed as advanced breast cancer and there is at least one measurable target lesion (based on RECIST V1.1):
l According to Response Evaluation Criteria in Solid Tumors, the target lesions must be accurately measured in at least one dimension; l No previous radiotherapy, intervention for target lesions;
- HER-2 positive [definition: including IHC (+++) or ISH positive; if IHC (++), HER-2 gene amplification detection should be further performed through fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH),silver-enhanced in situ hybridization (SISH) and other methods. The test reports of the clinical study site associated with the subject should be provided];
- The relapsed or metastatic patients who failed respond to the previous taxanes and/or anthracyclines, previous first-line chemotherapy for the metastatic lesion is acceptable;
- The expected survival is 3 months or longer;
- The function of major organs such as heart, liver and kidney are basically normal;
- ECOG score ≤2;
- Understand and voluntarily sign the written informed consent form;
2 Exclusion Criteria
- Pregnant or breastfeeding females; or women of childbearing potential who have positive serum/urine pregnancy tests; females of childbearing potential and their partners are unwilling to adopt effective contraceptive methods during the clinical study period and within 6 months after the end of the study;
- Received radiotherapy or chemotherapy within 4 weeks before randomization;
- Received anti-tumor endocrine therapy within 2 weeks before randomization;
- Previously received the standard anti-HER-2 treatment;
- Previously received capecitabine treatment;
- Subjects who previously received no taxanes; or subjects who respond to taxanes (no disease progression or intolerable toxic reactions);
- The major organ function of subjects is abnormal. The laboratory test results are presented below:
Hematology test:
l Absolute neutrophil count (ANC) < 1.5×109/L; l Platelet count (PLT) <100×109/L; l Hemoglobin (Hb) < 90 g/L (no blood transfusion within 14 days);
Hepatic and renal function tests:
l Bilirubin (TBIL)>1.5×ULN (upper limit of normal); l Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)>2.5×ULN; if there is any hepatic metastasis, ALT and AST >5×ULN; l Serum creatinine (Cr) >1.5×ULN; 8. Left ventricular ejection fraction ( LVEF)<50%; 9. The organ system status of subjects:
1 Subjects with known or suspected brain metastasis: subjects with evidence indicating signs or symptoms of brain metastasis are not allowed to participate in this study unless such brain metastasis is excluded by CT or MRI. However, subjects whose brain metastasis lesions have been controlled can be enrolled (no progression within at least 4 weeks after radiotherapy and/or no neurological symptom or sign after surgical resection, treatment with dexamethasone or mannitol is not necessary);
1 Evidence showing severe or uncontrolled systemic diseases (e.g. unstable or non-compensated respiratory, cardiac, hepatic or renal disease);
1 Uncontrolled active infection (≥CTCAE grade 2); l Any other malignant tumor within 5 years, excluding patients with completely cured cervical in situ carcinoma or basal cell or squamous epithelial cell skin cancer);
1 Subjects who have any of the following cardiac conditions:
- Unstable angina pectoris;
- Medical history of congestive heart failure;
- Previous medical history of myocardial infarction, coronary artery bypass grafting or coronary stent implantation;
- Clinically significant pericardial diseases and valvular heart diseases;
- Cardiac arrhythmias requiring therapeutic intervention;
- Any other cardiac diseases which may cause safety risks for subjects if they are enrolled in this study; 1 Uncontrolled hypertension (defined as screening systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥110mmHg); 10. Immunodeficiency medical history, including positive HIV detection; 11. Positive hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA of peripheral blood is not within the normal range; Positive hepatitis C virus antibody (HCV); 12. Subjects with drug abuse history or alcohol addiction history; 13. Participated in clinical study with drug intervention within one month before screening; 14. Subjects who are unsuitable for participation in this study at the discretion of the investigators.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: GB221+ Capecitabine tablets
test drug+capecitabine
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GB221:Lyophilized powder for injection; strength 110mg/bottle; the first administration of 8 mg/kg, intravenous drip for over 90 minutes; subsequently, the administration shall be given once every 3 weeks (one cycle), the dose is 6 mg/kg, intravenous drip for 30~90 minutes; The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study. Capecitabine:Tablets; 500mg/tablet, 12 tablets/box; Total daily dose 2000 mg/m2, orally twice daily, one dose each in the morning and evening, administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.
Otros nombres:
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Comparador de placebos: Placebo control + capecitabine tablets
placebo+capecitabine
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Placebo control:Lyophilized powder for injection; strength 110mg/bottle; the first administration of 8 mg/kg, intravenous drip for over 90 minutes; subsequently, the administration shall be given once every 3 weeks (one cycle), the dose is 6 mg/kg, intravenous drip for 30~90 minutes; The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study. Capecitabine:Tablets; 500mg/tablet, 12 tablets/box; Total daily dose 2000 mg/m2, orally twice daily, one dose each in the morning and evening, administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Progression-free survival, PFS
Periodo de tiempo: through study completion, an average of 2 year
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To evaluate the efficacy of GB221 as defined by progression-free survival in patients with breast cancer.
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through study completion, an average of 2 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Objective Response Rate, ORR
Periodo de tiempo: through study completion, an average of 2 year
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To evaluate the efficacy of GB221 as defined by overall response rate, in patients with breast cancer.
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through study completion, an average of 2 year
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Antidrug antibody, ADA
Periodo de tiempo: through study completion, an average of 2 year
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Antidrug antibody, ADA
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through study completion, an average of 2 year
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Overall survival, OS
Periodo de tiempo: through study completion, an average of 2 year
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To evaluate the duration from the first administration to death because of any reason in patients with breast cancer.
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through study completion, an average of 2 year
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PFS in the extended treatment phase
Periodo de tiempo: through study completion, an average of 2 year
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PFS in the extended treatment phase
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through study completion, an average of 2 year
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Colaboradores e Investigadores
Patrocinador
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
- GENOR GB221-003;V1.1
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 HER-2-positive Advanced Breast Cancer
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Carisma Therapeutics IncActivo, no reclutandoAdenocarcinoma | Neoplasias de Estómago | Cáncer | Cáncer de mama | Cáncer de cabeza y cuello | Carcinoma Hepatocelular | Cáncer colonrectal | Cancer de pancreas | Neoplasias Ováricas | Carcinoma Epitelial De Ovario | Carcinoma De Células De Transición | Neoplasia de mama | Cancer de prostata | Cáncer de las vías biliares y otras condicionesEstados Unidos
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BeiGeneReclutamientoCáncer de mama | Cáncer de pulmón de células pequeñas | Cáncer gástrico | Cáncer de ovarios | Cancer de prostata | Tumor sólido avanzado | Cáncer endometrial | Receptor hormonal positivo HER-2 negativo Cáncer de mama | Cáncer de mama con receptores de hormonas positivosEstados Unidos, Australia
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NKGen Biotech, Inc.RetiradoSarcoma | Cáncer de cuello uterino | Cáncer colonrectal | Cancer de pancreas | Cáncer de esófago | Cáncer de ovarios | Cáncer de pulmón de células no pequeñas | Cáncer metastásico | Cáncer de vejiga | Cáncer de mama triple negativo | Tumor sólido avanzado | Cáncer de mama HER2 positivo | Carcinoma de células escamosas... y otras condiciones
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Klus Pharma Inc.TerminadoCáncer de cuello uterino | Cáncer de cabeza y cuello | Carcinoma mucoepidermoide | Cancer de pancreas | Cáncer de próstata recurrente | Cáncer de pulmón | Cáncer de recto | Tumor solido | Cancer de prostata | Colangiocarcinoma | Cáncer de las vías biliares | Carcinoma de ovario recurrente | Cáncer de vejiga | Cáncer... y otras condicionesEstados Unidos
Ensayos clínicos sobre GB221
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Genor Biopharma Co., Ltd.TerminadoCáncer de mamaPorcelana
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Genor Biopharma Co., Ltd.TerminadoCáncer de mama metastásicoAustralia
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Genor Biopharma Co., Ltd.ReclutamientoCáncer de mama HER2 positivoPorcelana
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Veana TherapeuticsUniversity of WashingtonReclutamientoCáncer de mama anatómico en estadio IV AJCC v8 | Carcinoma de mama HER2 positivo | Carcinoma de mama metastásico | Carcinoma de mama refractarioEstados Unidos