Metastatic solid tumor
Conditions
Interventions
25µg dose group:Subjects will receive the 25µg NCP-CD47 siRNA formulation injection for a total of 5 doses, administered at 1-week intervals
50µg dose group:Subjects will receive the 50µg NCP-CD47 siRNA formulation injection for a total of 5 doses, administered at 1-week intervals
100µg dose group:Subjects will receive the 100µg NCP-CD47 siRNA formulation injection for a total of 5 doses, administered at 1-week intervals
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 patients: >= 18 years old; = 3 months; 5. More than 28 days since the previous chemotherapy/radiotherapy/surgery; 6. More than 6 weeks since the last use of nitrosourea or mitomycin C; 7. Good organ function, that is, within 14 days before enrollment, the relevant examination indicators meet the following requirements: (1) Blood routine examination: Hemoglobin >= 90g/L (no blood transfusion within 14 days); Neutrophil count > 1.5x10^9/L; Platelet count >= 80x10^9/L (2) Biochemical examination: Total bilirubin = 1.5×ULN (upper limit of normal value); Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) = 2.5×ULN; If there is liver metastasis, ALT or AST = 60ml/min (Cockcroft-Gault formula); (3) Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >= 50%. 8. Sign a written informed consent form (1) The subject must sign the EC-approved written informed consent form in accordance with the guidelines of the competent authority and the research institution and sign the date. The informed consent form must be signed before any program related to the protocol (not part of the subject's routine medical treatment) is carried out. (2) The subject must be willing and able to comply with the schedule of visits, treatment plans, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Participated in other drug clinical trials within 4 weeks; 2. The tumor is located close to major blood vessels or the trachea; 3. Has poorly controlled clinical symptoms or diseases of the heart, such as NYHA grade 2 or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention; 4. For female subjects: pregnant or lactating women; 5. The patient has active pulmonary tuberculosis, bacterial or fungal infection (>= grade 2 of NCI-CTCAE 5.0); active HIV infection, HBV infection, HCV infection; 6. Has a history of substance abuse and is unable to quit or has a mental disorder; 7. The subject has any active autoimmune disease or has a history of autoimmune disease (such as uveitis, enteritis, pituitaryitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of childhood asthma and no need for any intervention after adulthood can be included; subjects with asthma requiring bronchodilator medical intervention cannot be included); 8. The subject is receiving immunosuppressive treatment; 9. Has a history of drug abuse or known medical, psychological or social conditions, such as alcohol or drug abuse history; 10. Known to have an allergy, hypersensitivity reaction or intolerance to the study CD47 (including any excipients); any severe allergic history to drugs, food, vaccinations, such as anaphylactic shock, anaphylactic laryngeal edema, anaphylactic breathing difficulty, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.; 11. From the screening period to 12 months after the full injection of the drug, female subjects have a pregnancy plan or the partner of male subjects has a pregnancy plan; 12. According to the investigator's judgment, there are serious accompanying diseases that endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of dose-limiting toxicities (DLT) during the treatment with NCP-CD47 siRNA in the first treatment cycle, as well as the number of treatment interruptions due to treatment-related adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy rate and disease control rate of the NCP-CD47 siRNA formulation in treatment;The time from the administration of NCP-CD47 siRNA treatment until the first complete remission and partial remission;The duration of effective treatment with the NCP-CD47 siRNA formulation;The duration of disease stability achieved by the first administration of the NCP-CD47 siRNA formulation;The effect of NCP-CD47 siRNA formulation on progression-free survival time;Overall survival;Quality of life; | — |
Countries
China
Contacts
Public ContactXingchen Peng
West China Hospital, Sichuan University
Outcome results
None listed