Metastatic Solid Cancer
Conditions
Interventions
25µg Dose Group:Intratumoral injection of IL-22BP gene preparation, 25µg per dose, total 5 doses, with 1-week interval between doses
50µg Dose Group:Intratumoral injection of IL-22BP gene preparation, 50µg per dose, total 5 doses, with 1-week interval between doses
100µg Dose Group:Intratumoral injection of IL-22BP gene preparation, 100µg per dose, total 5 doses, with 1-week interval between doses
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; =3 months; 5. Interval from last chemotherapy/radiotherapy/surgery >28 days; 6. Interval from last use of nitrosourea or mitomycin C >6 weeks; 7. Good major organ function, i.e., relevant examination indicators within 14 days prior to randomization 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 =60ml/min (Cockcroft-Gault formula); (3) Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >=50%. 8. Signed written informed consent (1) Subjects must sign the EC-approved written informed consent form and date it in accordance with the guidelines of the competent authorities and research institutions. The informed consent form must be signed before performing any protocol-related procedures (parts not belonging to the subject's routine medical care). (2) Subjects must be willing and able to comply with the visits, treatment plans, laboratory examinations specified in the schedule, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Participation in another investigational drug clinical trial within 4 weeks. 2. Tumor located adjacent to major blood vessels or trachea. 3. Uncontrolled cardiac clinical symptoms or diseases, including: New York Heart Association (NYHA) Class >=2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular/ventricular arrhythmias requiring treatment or intervention. 4. Female patients who are pregnant or lactating. 5. Active pulmonary tuberculosis, bacterial or fungal infection (>=Grade 2 per NCI-CTCAE version 5.0); active human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection. 6. History of uncontrollable psychoactive substance abuse or presence of mental disorders. 7. Any active autoimmune disease or history of autoimmune disease (including but not limited to uveitis, enteritis, inflammatory bowel disease (Crohn's disease, ulcerative colitis), hypophysitis, nephritis, hyperthyroidism, hypothyroidism, hypothyroidism after previous immune checkpoint inhibitor treatment (can be stably controlled by hormone replacement therapy); subjects with vitiligo or childhood asthma in complete remission (no adult intervention required) are eligible; subjects with asthma requiring bronchodilator therapy are excluded). 8. Chronic diarrhea. 9. Receiving immunosuppressive therapy. 10. History of drug abuse or known medical, psychological, or social conditions that interfere with study compliance (e.g., alcoholism or illicit drug addiction). 11. Known hypersensitivity, allergy, or intolerance to the study drug IL-22BP (including any excipients), or history of severe allergic reactions to any drugs, foods, or vaccines (e.g., anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local Arthus reaction, etc.). 12. Female subjects planning pregnancy, or male subjects whose partner plans pregnancy, from screening until 12 months after the last study drug injection. 13. Any concomitant disease that, in the investigator’s judgment, may seriously compromise patient safety or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) and Treatment Discontinuation Due to Treatment-Related Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) and Disease Control Rate (DCR);Time to First Response (TTR) for Complete Response (CR) and Partial Response (PR);Duration of Response (DOR);Time to First Confirmed Stable Disease;Progression-Free Survival (PFS);Overall Survival (OS);Intratumoral IL22BP Expression (Gene and Protein Levels);Peripheral Blood Lymphocyte Subsets;Cytokine Levels;Immunofluorescence Staining of Tumor Microenvironment (Infiltrating Immune Cell Subsets);Quality of Life (QoL); | — |
Countries
China
Contacts
Public ContactPeng Xingchen
West China Hospital of Sichuan University
Outcome results
None listed