- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05293028
Study of F527 in Patients With Relapsed or Refractory Lymphoma
Phase I Clinical Study of Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of F527 in the Treatment of Patients With Relapsed or Refractory Lymphoma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Shanghai
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Shanghai, Shanghai, Porcelana, 200000
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
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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 aged ≥18 and ≤80 years old;
- Patients with histopathologically confirmed relapsed/refractory lymphoma; relapsed/refractory was defined as a patient who did not achieve a response (including complete or partial response) after the last systemic therapy regimen, or had disease progression after achieving a response or relapse;
- Subjects must have at least one measurable lesion assessed by the investigator (long diameter of lymph node>15mm, long diameter of extranodal lesion>10mm);
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2;
- Expected survival period ≥ 3 months;
The function of vital organs meets the following requirements (do not use any blood components and cytokines within 7 days before the first dose):
Blood routine: neutrophil count ≥1.5×109/L; platelet count ≥75×109/L; hemoglobin ≥95g/L; Liver function: TBIL≤1.5×ULN, ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Renal function: creatinine≤1.5×ULN; Coagulation function: International Normalized Ratio (INR)≤1.5×ULN and Activated Partial Thromboplastin Time (APTT)≤1.5×ULN;
- Understand the test procedures and content, and sign the informed consent voluntarily.
Exclusion Criteria:
- Special types of lymphoma such as primary/secondary central nervous system lymphoma, etc.;
- Patients with a history of other malignant tumors within the past 5 years, except for locally curable cancers (such as basal cell or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast, etc.);
- History of hemolytic anemia or Evans syndrome in the last three months;
- Positive direct antiglobulin test;
- Those who have used CD47-targeted drugs or signal-regulated protein alpha (SIRPα)-targeted drugs in the past;
- Received anti-tumor-related treatments such as anti-tumor chemotherapy, radiotherapy, biological therapy, or immunotherapy/immunomodulation therapy within 2 weeks before the first administration; the toxicity of previous anti-tumor therapy has not recovered to ≤ grade 1 (except for alopecia);
- Patients who have a history of organ transplantation or allogeneic bone marrow transplantation, or who have received autologous stem cell transplantation within 3 months before the first administration or have other severe immunodeficiency;
- HIV positive patients, syphilis-infected patients (RPR positive and TPPA positive) or active hepatitis (HBsAg positive and/or HBcAb positive, and HBV-DNA positive or higher than the upper limit of normal; HCV antibody positive and HCV- RNA positive or above the upper limit of normal);
- Patients with uncontrollable or severe cardiovascular disease, who have New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular diseases within 6 months before the first administration; Uncontrolled hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥100mmHg);
- Patients who have received any other clinical trial drug treatment within 4 weeks before the first dose;
- Patients who have received live attenuated vaccine within 4 weeks before the first dose;
- Patients who have a history of severe allergies, or who are known to be allergic to macromolecular protein preparations/monoclonal antibodies and any components of the investigational drug;
- Patients with a history of mental illness or drug abuse;
- Pregnant or lactating women, female patients or male patient partners who plan to become pregnant during the study period to 6 months after the last dose, and are reluctant to use a medically recognized effective contraceptive method (such as an intrauterine device or an intrauterine device) during the trial. condoms);
- Patients who are judged by the investigator to be unsuitable for enrollment.
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 |
---|---|
Experimental: Drug:F527
F527 is dose-escalated sequentially by accelerated titration and i3+3 design.
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0.001、0.01、0.1、0.3、1、3
and10 mg/kg QW
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
DLTs
Periodo de tiempo: Up to 21 days
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Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
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Up to 21 days
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Maximum Tolerated Dose (MTD)
Periodo de tiempo: Up to 21 days
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Maximum Tolerated Dose
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Up to 21 days
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RP2D
Periodo de tiempo: Up to 21 days
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PR2D will be determined by the sponsor and investigator based on the comprehensive data obtained on drug safety and tolerability, PK, preliminary anti-tumor efficacy, etc.
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Up to 21 days
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
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
- NTP-F527-001
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. .