Phase I Clinical Study of Dose-escalation Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of Recombinant Anti-FGFR Human-mouse Chimeric Monoclonal Antibody Injection BK011 in Patients with Advanced Malignant Solid Tumors
Fecha inicio: 18/5/2022 Fecha reclutamiento: Fecha final:
To observe the safety and tolerability of BK011 in patients with advanced solid tumors
To determine the maximum tolerated dose (MTD) of BK011 and appropriate recommended dose (RD) for follow-up studies
País: China Estado: En proceso Fase: I Promotor: Zhejiang Newind Biotechnology Co. Población de pacientes: Patients with advanced malignant solid tumors Área terapéutica: Oncology
Criterios de inclusión:
Voluntarily participate in clinical trials and sign informed consent;
Age 18 to 75 years old, no gender restrictions;
Subjects with advanced solid tumors confirmed by histology or cytology, who have failed standard treatment, or have no standard treatment plan, or are not suitable for standard treatment at this stage;
At least one measurable lesion (based on RECIST 1.1 criteria) Note: Lesions that have received prior radiation therapy are not considered target lesions unless there is definite progression after radiation therapy.
ECOG score 0~1 points;
Expected survival time = 3 months;
Main organ functions are basically normal, (have not received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or other medical supportive treatment within 14 days before study drug administration), laboratory tests during the screening period Values ??meet the following criteria: Absolute systemic neutrophil count > 1.5 × 109/L Platelets > 75 × 109/L Hemoglobin > 90 g/L Serum creatinine or creatinine clearance (CrCl) or glomerular filtration rate (GFR) ( Cockcroft-Gault formula < 1.5 x ULN or > 50 mL/min (for subjects with creatinine level = 1.5 x ULN) Total bilirubin (serum) < 1.5 x ULN or direct bilirubin < ULN (for total bilirubin AST (SGOT) and ALT (SGPT) < 2.5 × ULN or = 5 × ULN (for subjects with liver metastases) International Normalized Ratio (INR) or Prothrombin Time (PT ) < 1.5 × ULN unless the subject is receiving anticoagulation
Serum pregnancy test results of female subjects of childbearing age during the screening period were negative;
Subjects agreed to use reliable contraceptive methods from signing the informed consent to 30 days after the last dose. Including but not limited to: abstinence, vasectomy in men, female sterilization, effective IUD, effective contraceptives. Note: Women of non-reproductive age include permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) and menopause. Women =50 years of age were considered postmenopausal if they had stopped menstruating and had no other medical cause 12 months prior to the planned randomization date. Women <50 years of age were considered postmenopausal if they had stopped menstruating for 12 months or more after cessation of exogenous hormone therapy and had follicle-stimulating hormone (FSH) levels within the postmenopausal range.
Criterios de exclusión:
Received chemotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor drug treatments (nitrosoureas or mitomycin C, oral fluorouracils and small molecule targeted drugs, anti-tumor indications) within 4 weeks before the first dose of traditional Chinese medicine within 2 weeks before the first dose).
Received inactivated vaccine (such as COVID 19 inactivated vaccine, influenza vaccine, etc.) within 8 weeks before the first dose; or vaccinated with the new coronavirus adenovirus vector vaccine or mRNA vaccine within 12 weeks before the first dose.
Received other unmarketed clinical research drugs or treatments within 4 weeks before the first dose.
Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose, or elective surgery during the trial period.
Suffering from clinically significant skin diseases or a history of skin diseases requiring long-term treatment when participating in the study, including but not limited to psoriasis, moderate to severe atopic dermatitis, viral infections, etc.
Received systemic corticosteroids (prednisone >10 mg/day or equivalent dose of similar drugs) or other immunosuppressive therapy within 14 days before the first dose; except for the following cases: topical, ocular, intra-articular , intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylaxis (eg, prophylaxis of contrast medium allergy).
Previous antitumor therapy targeting EGRF (eg, Erbitux) was ineffective.
Those who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past.
The adverse reactions of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade evaluation = grade 1 (except for toxicities such as hair loss that the researchers judged to be no safety risk).
CNS metastases or meningeal metastases with clinical symptoms, or other evidence that patients with central nervous system metastases or meningeal metastases have not been controlled, are judged by the investigator to be unsuitable for enrollment.
Patients with active infection within 1 week before the first dose and requiring systemic anti-infective treatment.
A history of immunodeficiency, including a positive HIV antibody test.
Patients with active HBV and HCV infection; except those with stable hepatitis B after drug treatment (judged by the investigator) and cured hepatitis C (negative HCV RNA test).
Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to: Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia, II-III degree atrioventricular block, etc. requiring clinical intervention; Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months before the first dose; New York Heart Association (NYHA) cardiac function class = II or left ventricular ejection fraction (LVEF) <50%; Uncontrolled hypertension (systolic blood pressure 150mmHg and/or diastolic blood pressure >100mmHg) after receiving 2 or more antihypertensive drugs; Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, use of any concomitant medication known to prolong the QT interval.
The clinically uncontrollable third space effusion was judged by the investigator to be unsuitable for inclusion.
Known alcohol or drug dependence.
Mental disorder or poor compliance.
Pregnant or breastfeeding women.
The investigator believes that the subjects are not suitable for participating in this clinical study for other reasons.
Género: Both Edad: Adults; Older Adults Medicación: Anticancer, other; Monoclonal antibody, chimaeric Duración del tratamiento: No disponible
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