Tumor
Conditions
Interventions
experimental group:BM001
Sponsors
Luoyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male or female patients, aged 18 to 75 years; 2.Patients with advanced malignant tumors that have been clearly diagnosed by pathology and/or cytology, such as liver cancer, ovarian cancer, and prostate cancer. 3.Patients with advanced solid tumors who have failed or cannot tolerate standard treatment; 4.General condition score ECOG 0-2 points; 5.The expected survival period is more than 3 months; 6.According to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1 version), the patient has at least one measurable or evaluable tumor lesion with the longest diameter at baseline >=10mm (if it is a lymph node, the short diameter is required to be >= 15mm). The lesion is suitable for intratumoral injection (the length of the lesion is at least greater than or equal to 10 mm); 7.The patient should have sufficient bone marrow reserve function, or no liver and kidney coagulation dysfunction, laboratory test values must meet the following conditions: (1)Absolute neutrophil count > 1.5 x 10^9/L, and white blood cell count > 3.5 x 10^9/L; (2)Platelet count > 80 x 10^9/L; (3)Hemoglobin > 90 g/L; (4)Serum creatinine 30 mL/min; (5)If there is no confirmed liver metastasis, AST, ALT < 2.5 x ULN; if there is confirmed liver metastasis, AST, ALT < 5 x ULN; (6)If there is no liver metastasis, total bilirubin < 1.5 x ULN; if there is liver metastasis or Gilbert syndrome patients (high indirect bilirubinemia), total bilirubin < 3 x ULN; g.International normalized ratio (INR) < 1.5, and activated partial prothrombin time (APTT) < 1.5 x ULN; 8.The patient has no brain metastases (except for patients with asymptomatic brain metastases, or patients who have had brain metastases but have been treated for more than 4 weeks of stable disease); 9.The patient voluntarily signs the informed consent form, and the expected compliance is good.
Exclusion criteria
Exclusion criteria: 1.Known or suspected allergies to study drug ingredients or their analogs; 2.The patient has any instability or any other diseases or medical conditions that may affect its safety or research compliance, any serious or uncontrolled systemic diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, and uncontrolled diabetes. Controlled high blood pressure, severe infections, active peptic ulcers, abnormal immune function, etc.; 3.Cardiovascular and cerebrovascular diseases/symptoms/indications that meet any of the following conditions: (1)Average resting QTc>470 ms (corrected QT interval [corrected by Fridericia formula]), the average of 3 ECG QTc, the QT interval measurement should be from the beginning of the QRS complex to the end of the T wave); (2)Any clinically important resting ECG abnormalities in rhythm, conduction or morphology, such as complete left bundle branch block, 2 and 3 degree heart block, PR interval> 250 ms, etc. (3)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, or unexplained sudden death in first-degree relatives under 40, Or any combination drug that is known to prolong the QT interval; (4)Left ventricular ejection fraction (LVEF) < 50%; (5)Those who have a history of decreased myocardial contractility and have related symptoms within 6 months before the study administration: such as chronic congestive heart failure, pulmonary edema, or decreased cardiac ejection fraction; (6)A history of acute and chronic cardiovascular and cerebrovascular diseases, and related symptoms within 6 months before the study administration: such as myocardial infarction, severe or unstable angina, cerebral infarction, cerebral hemorrhage, or transient cerebral ischemia Seizures, etc.. 4.People suffering from other malignant tumors or with a history of other malignant tumors, except for those who have been effectively controlled, non-invasive, basal cell carcinoma of the skin or squamous cell carcinoma, cervical carcinoma in situ and breast ducts that have not been recurred or metastasized for 5 years cancer; 5.The lesion cannot meet the requirement of 1 mL volume injected into the tumor; 6.For women of childbearing age (postmenopausal women must have been menopausal for at least 12 months to be considered infertile). Serum pregnancy test results are positive within 7 days before the first dose of the study drug; or, as judged by the investigator, during the study period. And within 3 months after the last administration of the study drug, those who are willing to become pregnant, breastfeeding, or unwilling to use effective contraceptive measures (including male subjects and their female spouses of childbearing age); 7.Within 4 weeks before the first administration of the study drug, (1)Received chemotherapy, radiotherapy, biological/targeted drug therapy, immune drug therapy and other anti-tumor treatments; (2)Have received major surgery; (3)Participated in other clinical trials, used or is using other experimental drug treatments (except for non-interventional drug clinical trials). 8.Other severe, acute, or chronic clinical or mental diseases or laboratory abnormalities that may increase the risk of research and research medication, or may interfere with the results of the research; 9.Patients with active autoimmune diseases or a history of autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse effect; | — |
Countries
China
Contacts
Public ContactWang Zhanhui
Luoyang Central Hospital
Outcome results
None listed