Advanced or metastatic solid tumors
Conditions
Interventions
25µg Dose Group:Non-cationic peptide-IL-22BP mRNA formulation, 25µg, intratumoral injection, once weekly for 5 doses
50µg Dose Group:Non-cationic peptide-IL-22BP mRNA formulation, 50µg, intratumoral injection, once weekly for 5 doses
100µg Dose Group:Non-cationic peptide-IL-22BP mRNA formulation, 100µg, intratumoral injection, once weekly for 5 doses
Sponsors
West China Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients: >=18 years old; =3 months; 6. More than 28 days since previous chemotherapy/radiotherapy/surgery; 7. More than 6 weeks since previous use of nitrosourea or mitomycin C; 8. Good major organ function, meaning 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 >1.5×10^9/L; Platelet count >=80×10^9/L (2) Biochemical examination: Total bilirubin =60ml/min (Cockcroft-Gault formula); (3) Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >=50%. 9. Signed written informed consent (1) Subjects must sign the EC-approved written informed consent form according to the guidelines of the competent authorities and research institutions, dated. 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 tests specified in the schedule, and comply with other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical drug trial within 4 weeks 2. Tumor located adjacent to major blood vessels or trachea 3. Poorly controlled cardiac conditions: NYHA class >2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring treatment 4. Pregnant or breastfeeding women 5. Active pulmonary tuberculosis, bacterial or fungal infection (=Grade 2 per NCI-CTCAE v5.0); HIV infection, active HBV or HCV infection 6. History of psychotropic substance abuse that cannot be discontinued, or mental disorders 7. Active autoimmune disease or history of autoimmune disease (exceptions: vitiligo; childhood asthma in complete remission) 8. Currently receiving immunosuppressive therapy 9. History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism, drug addiction) 10. Known allergy, hypersensitivity, or intolerance to IL-22BP or any excipient; history of severe allergic reactions to any drug, food, or vaccine 11. Female subjects with pregnancy plans or male subjects whose partners have pregnancy plans from screening through 12 months after the last dose 12. Any serious concomitant disease that, in the investigator's judgment, would jeopardize patient safety or ability to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the incidence of dose-limiting toxicities (DLTs) during the first treatment cycle of NCP-IL-22BP mRNA administration.;Number of treatment interruptions due to treatment-related adverse events.; | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of NCP-IL-22BP mRNA treatment, including objective response rate (ORR) and disease control rate (DCR).;Time to first response (TFR) with NCP-IL-22BP mRNA treatment, defined as the time from treatment initiation to the first confirmed complete response (CR) or partial response (PR).;To evaluate the duration of response (DOR), defined as the time from the first confirmed CR or PR to the first occurrence of disease progression or death from any cause.;To evaluate the duration of stable disease (SD), defined as the time from the first confirmed SD to the first occurrence of disease progression or death from any cause.;To evaluate progression-free survival (PFS), defined as the time from the first administration of NCP-IL-22BP mRNA treatment to the first occurrence of disease progression or death from any cause.;To evaluate overall survival (OS), defined as the time from the first administration of NCP-IL-22BP mRNA treatment to death from any cause.; | — |
Countries
China
Contacts
Public ContactPeng Xingchen
West China Hospital of Sichuan University
Outcome results
None listed