Tumor
Conditions
Interventions
Experimental group:BM201 injection with sintilimab and radiotherapy
Sponsors
Nanjing Drum Towel Hospital The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. In screening period, the age should be = 18 years old and = 75 years old; 2. The Eastern Oncology Collaborative Group (ECOG) score of 0-2; 3. Expected survival time of more than 3 months; 4. Solid tumor patients confirmed by histology or cytology as unresectable locally advanced or metastatic, with standard treatment failure or inability to receive standard treatment; Cohort 1: Advanced melanoma; Cohort 2: Advanced soft tissue sarcoma; Cohort 3: Other advanced solid tumors except for Cohort 1 and 2; 5. According to the relevant evaluation criteria for tumor immunotherapy (irRECIST), patients must have at least one measurable tumor lesion, and the baseline lesion volume must be = 6.00 × 103 mm3) and the lesion is suitable for intratumoral injection; 6. Women of childbearing age have negative serum pregnancy test results within 7 days before the first dose/radiation therapy, and are willing to use effective contraception methods during the study period and within 3 months after the last dose; And it must be non lactating. Male patients with female partners of childbearing age must agree to use effective methods of contraception during the study period and within 3 months after the last dose; 7. Prior anti-tumor therapy with a distance of = 4 weeks between initial administration/radiotherapy, and the toxicity related to anti-tumor therapy has returned to = 1 level (NCI CTCAE 5.0), except for hair loss, vitiligo, stable hypothyroidism after hormone replacement therapy, etc 8. If no blood transfusion, erythropoietin (EPO), recombinant human granulocyte macrophage colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), thrombopoietin (TPO), or other corrections have been received within 7 days before the first dose/radiotherapy, the laboratory test values within 7 days before the first dose/radiotherapy must meet the following conditions: a) Blood routine: Absolute neutrophil count = 1.5 × 109/L, white blood cell count = 3 × 109/L, platelet count = 80 × 109/L, hemoglobin = 90 g/L; b) Renal function: serum creatinine = 1.5 × Upper limit of normal value (ULN) and creatinine clearance rate = 30 mL/min (calculated by Cockroft Fault formula *); c) Liver function: Total bilirubin<1.5 × ULN, AST, ALT < 2.5 × ULN (if confirmed liver metastasis, AST, ALT<5 × ULN, total bilirubin<3 × ULN); d) Coagulation function: International standardized ratio (INR)<1.5 × ULN with activated partial prothrombin time (APTT)<1.5 × ULN. Subjects receiving full dose oral anticoagulant therapy must receive a stable dosage (at least 14 days); Individuals receiving warfarin treatment must have an INR = 3.0; Individuals receiving low molecular weight heparin treatment are allowed to be included in the group; 9. After sufficient communication between the researcher and the subject, they voluntarily sign an informed consent form and are willing to follow the experimental treatment plan and visit plan
Exclusion criteria
Exclusion criteria: 1. Patients who are known to have active brain metastasis and/or cancerous meningitis during the screening period. However, the following subjects are allowed to be enrolled: a) Asymptomatic brain metastasis patients (i.e. without progressive central nervous system symptoms caused by brain metastasis, no need to use corticosteroids, and lesion size = 1.5 cm) can participate, but regular brain imaging examinations of the disease site are required; b) Subjects who have been treated and have stable brain metastases for at least 4 weeks have no evidence of new or expanded brain metastases, and steroids have been discontinued 3 days before drug administration/radiotherapy in clinical trials. Stable brain metastasis should be determined before the first administration of drugs in clinical trials. 2. Individuals who are known or suspected to be allergic to any investigational medication ingredient; 3. Subjects who are known to have active hepatitis B [hepatitis B B surface antigen (HBs Ag) positive and/or hepatitis B core antibody (HBc Ab) positive and hepatitis B virus deoxyribonucleic acid (HBV-DNA) = 2800 copies/ml or = 500 IU/ml] or hepatitis C virus ribonucleic acid (HCV-RNA) positive, human immunodeficiency virus (HIV) antibody, treponema pallidum antibody test results positive; 4. The patient has any other disease or medical state that is unstable or may affect his safety or research compliance, any serious or uncontrolled systemic disease, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled or poorly controlled high blood pressure (systolic pressure>140 mmHg and/or diastolic pressure>90 mmHg), serious infection (including active infection within 14 days before the first administration/radiotherapy) Active gastrointestinal ulcers, immune dysfunction, etc; 5. Cardiovascular and cerebrovascular diseases/symptoms/indications that meet any of the following conditions: a) Resting QTcF>470 ms [corrected QT interval (corrected by Fridericia formula), collect electrocardiogram after 10 minutes of rest]; b) Any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (electrocardiogram), such as complete left bundle branch block, 2nd and 3rd degree heart block, PR interval>250 ms, etc; c) 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 the age of 40, or any known combination medication that can prolong the QT interval; d) Left ventricular ejection fraction (LVEF)<50%; e) Individuals with a history of decreased myocardial contractility and related symptoms within 6 months prior to drug administration/radiotherapy in clinical trials, such as chronic congestive heart failure, pulmonary edema, or decreased cardiac ejection fraction; f) Individuals who have a history of acute or chronic cardiovascular and cerebrovascular diseases and have experienced related symptoms within 6 months before drug administration/radiotherapy in clinical trials, such as myocardial infarction, severe or unstable angina, cerebral infarction, cerebral hemorrhage, or transient ischemic attacks; 6. For those who have merged with other malignant tumors or have a history of other malignant tumors, excluding skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ, and breast ductal carcinoma that have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limited toxicity (DLT);Maximum Tolerated Dose;Recommended dosage for combination medication;Safety assessment (vital signs, physical examination, laboratory indicators, adverse events (AE), immune related adverse events (irAE), severe adverse events (SAE)); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) of injection lesions;Duration of Remission (DOR) of injection lesions;disease control rate (DCR) of injection lesions;ORR;DOR;DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactBaorui Liu
Nanjing Drum Towel Hospital The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed