solid tumors
Conditions
Interventions
Low dose group:injection 1×10^7 PFU
Medium dose group:injection 3×10^7 PFU
High dose group:injection1×10^8 PFU
laryngocarcinoma:recommended phaseII dose,RP2D
small cell lung cancer:recommended phaseII dose,RP2D
hepatoma:recommended phaseII dose,RP2D
Breast cancer:recommended phaseII dose,RP2D
colorectal cancer:recommended phaseII dose,RP2D
Neuroendocrine carcinoma:recommended phaseII dose,RP2D
Sponsors
Hubei Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Patients with pathologically proven advanced solid tumors (laryngeal carcinoma, small cell lung cancer, liver cancer, breast cancer, colorectal cancer, neuroendocrine carcinoma); 2)Have received at least once standard of care that has failed ; 3)A measurable lesion was confirmed according to RECIST version 1.1,lesion located in the area of previous radiotherapy or other local regional treatment sites are generally not used as target lesion, unless there is definite progress; 4)There were lesions that could accept tumor administration, Non-lymph node lesions were required to be =1cm long ,and lymph node lesions were required to be =1.5cm short; 5)ECOG performance score of 0-1; 6)Age range from 18 to 75 years old (including boundary values), gender is not limited; 7)Expected survival =3 months; 8)The adverse effects of previous antitumor therapy returned to CTCAE 5.0 scale evaluation = level 1 (except for toxicities without safety risks as determined by the investigators, such as alopecia, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.); 9)Brain metastases: Must be asymptomatic or treated and stable for at least 1 month after withdrawal of steroids and anticonvulsants (prior to study treatment). Patients with suspected brain metastases during the screening period should undergo brain CT/MRI before entering the study; 10)Blood routine: white blood cell count =3.0×10^3/mm3 (3.0×10^9/L), neutrophil =1.5×10^3/mm3 (1.5×10^9/L); Platelet =80×10^3/mm3 (80×10^9/L); Hemoglobin =8.0g/dL (80g/L); 11)Coagulation function: International standardized ratio (INR) =1.5×ULN (upper limits of normal); Activated partial thromboplastin time (APTT) =1.5×ULN; 12)Liver function indexes: aspartate aminotransferase (AST) =3×ULN; Alanine aminotransferase (ALT) =3×ULN Total bilirubin (TBIL) =1.5×ULN;for liver cancer or liver metastasis: ALT=5×ULN, AST=5×ULN, TBIL=3×ULN; 13)Indicators of renal function: creatinine clearance (CrCl) = 60mL/min/1.73m2; 14)Female subjects of reproductive age must undergo a negative serum pregnancy test within 3 days prior to study drug initiation and be willing to use a medically approved highly effective contraceptive (e.g., IUD or condom) during the study period and within 3 months after the last study drug administration; Male subjects whose partner is a woman of reproductive age should agree to use an effective method of contraception during the study period and within 3 months after the last study administration; 15)The patient or guardian must sign the informed consent, must be able to read and understand the informed consent, and must sign the informed consent to show that they understand the nature of the study.
Exclusion criteria
Exclusion criteria: 1)Previous or current malignant neoplasms of other types, except the following:a. Completely cured Basal cell carcinoma of the skin, superficial bladder carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the breast, or cervical carcinoma in situ;b. Secondary primary cancer that has been eradicated and has not recurred within 5 years; 2)People who are allergic (more than two drugs, food, pollen) or are known to be allergic to recombinant WNV-HCD86 for injection and any excipients it contains [Na2HPO4, L-glutamate, L-arginine, sucrose, recombinant human blood albumin (plant source)]; 3)Those who have received oncolytic virus therapy; 4)Those who have received cell therapy; 5)Unable to undergo CT or magnetic resonance imaging (MRI) and unable to tolerate imaging contrast media; 6)HIV antigen antibody complex test positive, treponema pallidum antibody positive, hepatitis B surface antigen (HBsAg positive and HBV DNA>500 IU/ml), hepatitis C antibody positive patients; Liver cancer, active hepatitis B, HBsAg positive HBV DNA>2000 IU/ml; Active hepatitis C, antibody positive and HCV RNA positive; 7)Liver cancer patients with Child-Pugh B grade 7 or above; 8)Patients with a history of immune deficiency or autoimmune diseases such as systemic lupus erythematosus, polymyositis, insulin-dependent diabetes mellitus, etc 9)Severe or medically unmanageable hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >100mmHg after antihypertensive treatment); 10)Blood glucose control is not up to standard; 11)Severe cardiovascular disease, including but not limited to:a. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, QTcF interval > 450ms for men and > 470ms for women;b. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurring within 6 months prior to initial administration;c. New York Heart Association cardiac function Grade =II or left ventricular ejection fraction (LVEF) < 50%; 12)Risk of thrombosis:a. History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to initial administration (port of implantable intravenous infusion or catheter-derived thrombosis, or superficial venous thrombosis is not considered "severe" thromboembolism);b. Other diseases identified by the investigator as having a higher risk of thrombosis in the future; 13)There are systemic infections, including but not limited to active tuberculosis, bacteria (e.g. Streptococcus pneumoniae), fungi (e.g. Candida) or viruses (e.g. Novel coronavirus) that require systemic treatment; 14)The effusion of pleural cavity and abdominal cavity that affected the operation of administration was determined by the investigator; 15)Received any vaccine within 30 days before the start of study drug administration; 16)Participated in other clinical studies within 28 days prior to initiation of study drug administration; 17)The investigator assessed as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT,Dose-limiting toxicity;ORR,Overall Response Rate;Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of Complete Response;rate of Partial Response;In vivo processes of the drug;immunogenicity;Progression Free Survival;Duration of Response;Overall Survival; | — |
Countries
China
Contacts
Public ContactXinJun Liang
Hubei Cancer Hospital
Outcome results
None listed