- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05212896
An Exploratory Clinical Study of BC006 in Patients With Advanced Solid Tumors
16 de enero de 2022 actualizado por: Dragonboat Biopharmaceutical Company Limited
An Exploratory Clinical Study to Evaluate the Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BC006 Monoclonal Antibody Injection in Patients With Advanced Solid Tumors Including Giant Cell Tumor of Tendon Sheath
This is a first in human, open-label, exploratory phase I clinical study including dose escalation (Ia) and dose expansion (Ib) stage.
It aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BC006 in giant cell tumor of tendon sheath (GCTTS) and other advanced solid tumors.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
90
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yuan Peng
- Número de teléfono: #86#021-50276381
- Correo electrónico: yuan.peng@dragonboatbio.com
Copia de seguridad de contactos de estudio
- Nombre: Ting Yan
- Número de teléfono: #86#021-50276381
- Correo electrónico: ting.yan@dragonboatbio.com
Ubicaciones de estudio
-
-
Shanghai
-
Shanghai, Shanghai, Porcelana, 200000
- Reclutamiento
- Dragonboat Biopharmaceutical,Co.,Ltd
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Contacto:
- Yuan Peng
- Número de teléfono: #86#021-5027638
- Correo electrónico: yuan.peng@dragonboatbio.com
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Contacto:
- Ting Yan
- Número de teléfono: #86#021-5027638
- Correo electrónico: ting.yan@dragonboatbio.com
-
Investigador principal:
- Li Zheng
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Key Inclusion Criteria:
- Signed informed consent form.
- Age ≥ 18 years.
Clinical diagnosis:
Dose Escalation: Phase Ia
- Histologically or cytologically confirmed GCTTS: initial treatment unresectable, or postoperative recurrence unresectable, or refuse surgical treatment.
- Patients with histologically or cytologically confirmed advanced solid tumor, who have progression after prior SOC therapy, or who intolerant to SOC, or for whom there is no SOC therapy available.
Dose Expansion: Phase Ib
- Cohort 1: Histologically or cytologically confirmed GCTTS: initial treatment unresectable, or postoperative recurrence unresectable, or refuse surgical treatment.
- Cohort 2~4: Patients with histologically or cytologically confirmed advanced solid tumor which is sensitive to Ia treatment,who have progression after prior SOC therapy, or who intolerant to SOC, or for whom there is no SOC therapy available.
- Life expectancy ≥ 12 weeks.
- Ia: at least one evaluable lesion; Ib: at least one measureable lesion as defined by RECIST V1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Evidence of adequate organ function by standard laboratory tests:
- Adequate hematological function: Hemoglobin (Hgb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, Platelets (Plts) ≥ 90 × 109/L.
- Adequate liver function: Total bilirubin ≤ 1.5 × the upper limit of normal (ULN), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) ≤ 2.5 × ULN (AST≤ 5 × ULN, ALT≤ 5 × ULN for subjects with liver metastases).
- Adequate renal function: Creatinine ≤ 1.5 × ULN, or Creatinine clearance by Cockcroft Gault formula ≥ 50 mL/min.
- Adequate Coagulation function: Activated partial thrombin time (APTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, international standardized ratio (INR) ≤ 1.5 × ULN.
- Female patients of child-bearing potential or male patients with a female partner(s) of child-bearing potential must agree to use reliable contraceptive methods (hormonal, condoms or abstinence) for the duration of the study and for 6 months after the last dose of BC006; women of child-bearing potential must have a negative blood or urine pregnancy test within 7 days prior to enrollment.
Key Exclusion Criteria:
- Prior anti-tumor therapies such as radiotherapy, chemotherapy, targeted therapy, endocrine therapy, immunotherapy or other investigational agents within 4 weeks before the first dose of BC006.
- Prior treatment with any anti-CSF-1R inhibitor.
- Any toxicity from previous anti-tumor treatments have not recovered to CTCAE V5.0 grade ≤ 1 (except treatment-related alopecia).
- Patients with untreated or clinically symptomatic brain metastases, spinal cord compression, cancerous meningitis, or patients with evidence that brain and spinal cord metastases have not been controlled (Patients with previously treated brain metastases may participate provided they are clinically and imaging stable for at least 4 weeks prior to first dose of BC006, have no evidence of cerebral edema and are off steroids).
- Patients with severe cardiovascular diseases: cardiac arrhythmia requiring clinical intervention; acute coronary syndrome, congestive heart failure, stroke or other ≥ grade 3 cardiovascular events within 6 months; New York Heart Association (NYHA) cardiac function ≥ grade II or left ventricular ejection fraction (LVEF) <50%; poorly controlled hypertension as judged by the investigator are not suitable to participate in the study.
- Receipt of a live vaccine within 4 weeks prior to the first dose of BC006 or anticipation that such a live vaccine will be required during the study.
- Patients with symptomatic pleural, abdominal, or pericardial effusions that require repeated puncture and drainage treatment and cannot be relieved; patients with stable disease after receiving treatment (including therapeutic thoracentesis or abdominal puncture) are allowed to enroll.
- In the opinion of the investigator, patients have any clinical or laboratory examination abnormality or other conditions that are not suitable to participate in the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Dose Escalation: Phase Ia
Participants will receive escalating doses of BC006 at assigned dose (0.08, 0.3, 1.0, 3.0, 10, 20 mg/kg) via intravenous (IV) infusion every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 48 weeks of treatment, whichever occurs first.
|
BC006 monoclonal antibody injection
|
Experimental: Dose Expansion: Phase Ib Cohort 1
Participants with GCTTS will receive BC006 at recommended dose for expansion (RDE) IV every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 24 weeks of treatment, whichever occurs first.
|
BC006 monoclonal antibody injection
|
Experimental: Dose Expansion: Phase Ib Cohort 2~4
Participants with other solid tumors will receive BC006 at RDE IV every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 48 weeks of treatment, whichever occurs first.
|
BC006 monoclonal antibody injection
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Periodo de tiempo: Up to 28 days
|
Dose Escalation: Phase Ia
|
Up to 28 days
|
Maximum Tolerated Dose (MTD) of BC006
Periodo de tiempo: Up to 28 days
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Dose Escalation: Phase Ia
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Up to 28 days
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Recommended Dose for Expansion (RDE) of BC006
Periodo de tiempo: Through study completion, an average of 1 year
|
Dose Escalation: Phase Ia
|
Through study completion, an average of 1 year
|
Number of Participants with TEAEs
Periodo de tiempo: Through study completion, an average of 1 year
|
Graded according to the NCI CTCAE V5.0
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Through study completion, an average of 1 year
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Number of Participants with SAEs
Periodo de tiempo: Through study completion, an average of 1 year
|
Graded according to the NCI CTCAE V5.0
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Through study completion, an average of 1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cmax
Periodo de tiempo: From first dose of BC006, an average of 6 months
|
Pharmacokinetic parameter, observed Maximum Serum Concentration (Cmax) of BC006
|
From first dose of BC006, an average of 6 months
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Tmax
Periodo de tiempo: From first dose of BC006, an average of 6 months
|
Pharmacokinetic parameter, Time-to-Maximum (Tmax) of BC006
|
From first dose of BC006, an average of 6 months
|
AUC0-t
Periodo de tiempo: From first dose of BC006, an average of 6 months
|
Pharmacokinetic parameter, area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration (AUC0-t) of BC006
|
From first dose of BC006, an average of 6 months
|
t1/2
Periodo de tiempo: From first dose of BC006, an average of 6 months
|
Pharmacokinetic parameters, apparent Terminal Half-life (t1/2) of BC006
|
From first dose of BC006, an average of 6 months
|
Pharmacodynamic (PD) Parameters
Periodo de tiempo: From first dose of BC006, an average of 6 months
|
CSF-1 levels in peripheral blood
|
From first dose of BC006, an average of 6 months
|
Number of Participants with Anti-BC006 Antibodies (ADAs)
Periodo de tiempo: From first dose of BC006, an average of 6 months
|
ADA titer and Neutralizing Antibodies (NAbs) analysis will be performed when ADA is positive
|
From first dose of BC006, an average of 6 months
|
Objective Response Rate (ORR)
Periodo de tiempo: From first dose of BC006, up to 2 years
|
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
|
From first dose of BC006, up to 2 years
|
Disease Control Rate (DCR)
Periodo de tiempo: From first dose of BC006, up to 2 years
|
Disease control rate (DCR) is defined as the proportion of the optimal time response of CR, PR, disease stable (SD) (i.e.
CR+PR+SD) between initiation of the trial drug and withdrawal from the trial, as assessed according to RECIST Version 1.1
|
From first dose of BC006, up to 2 years
|
Progression-Free Survival (PFS)
Periodo de tiempo: From first dose of BC006, up to 2 years
|
Progression-free survival (PFS) is defined as the time elapsed from the day the study drug was first administered until the first imaging assessment of disease progression (PD) or death from any cause.
|
From first dose of BC006, up to 2 years
|
Duration of Response (DOR)
Periodo de tiempo: From first dose of BC006, up to 2 years
|
The duration of response (DOR) is defined as the time from the beginning of the first tumor assessment as PR or CR to the first assessment as PD or death from any cause.
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From first dose of BC006, up to 2 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Li Zheng, West China Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
26 de noviembre de 2021
Finalización primaria (Anticipado)
1 de diciembre de 2024
Finalización del estudio (Anticipado)
1 de diciembre de 2024
Fechas de registro del estudio
Enviado por primera vez
4 de enero de 2022
Primero enviado que cumplió con los criterios de control de calidad
16 de enero de 2022
Publicado por primera vez (Actual)
28 de enero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de enero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
16 de enero de 2022
Última verificación
1 de junio de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BC006-Ⅰ-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .