Uveal melanoma
Conditions
Interventions
Dose group 3:SKV-07 Injection Low dose: 1×10^10 pfu/eye
Dose group 3:SKV-07 Injection Low dose: 1×10^9 pfu/eye
Dose group 3:SKV-07 Injection Low dose: 5×10^9 pfu/eye
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Male or female, aged >=18 years and =6 months; 6.Adequate major organ function: hematology, liver and kidney function, and coagulation function meet the required criteria; 7.Signed written informed consent;
Exclusion criteria
Exclusion criteria: 1.Participation in another clinical trial of an investigational drug within the past 4 weeks; 2.Cases with systemic metastasis; 3.Tumor location unsuitable for administration; 4.Presence of poorly controlled cardiac clinical symptoms or diseases, such as: NYHA class >=2 heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 5.For female subjects: pregnant or lactating women; 6.Active pulmonary tuberculosis, bacterial or fungal infection (>= grade 2 according to NCI-CTCAE 5.0); HIV infection, active HBV infection, or HCV infection; 7.History of substance abuse (psychoactive drugs) that cannot be abstained from, or history of mental disorders; 8.Presence of any active autoimmune disease or history of autoimmune disease (e.g., including but not limited to: uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism); subjects with vitiligo or childhood asthma that has completely resolved without any intervention in adulthood may be included; subjects requiring bronchodilators for medical intervention for asthma are excluded; 9.Subject is receiving immunosuppressive therapy; 10.History of substance abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug addiction; 11.Known allergy, hypersensitivity, or intolerance to the investigational oncolytic virus (including any excipients). History of severe allergic reactions to any drug, food, or vaccine, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, or Arthus reaction; 12.Female subjects planning to become pregnant or male subjects whose partners are planning to become pregnant from the screening period through 12 months after the full course of injections; 13.According to the investigator's judgment, any concomitant disease that would seriously jeopardize patient safety or interfere with the patient's completion of the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor size;Quality of life assessment;Viral shedding monitoring; | — |
Countries
China
Contacts
Public ContactFang Lu
West China Hospital of Sichuan University
Outcome results
None listed