Patients with histologically confirmed, refractory advanced or metastatic malignant solid tumors who have failed second-line therapy and for whom no standard clinical treatment is available (e.g., patients with advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, or malignant melanoma)
Conditions
Interventions
25µg PAN-NeoVax group:Participants will receive the 25µg RNA neoantigen vaccine injection, consisting of 5 doses of priming immunization followed by subsequent personalized treatment. During the primi
50µg PAN-NeoVax group:Participants will receive the 50µg RNA neoantigen vaccine injection, consisting of 5 doses of priming immunization followed by subsequent personalized treatment. During the primi
100µg PAN-NeoVax group:Participants will receive the 100µg RNA neoantigen vaccine injection, consisting of 5 doses of priming immunization followed by subsequent personalized treatment. During the pri
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged >=18 and =3 months; 5. At least 28 days since prior chemotherapy, radiotherapy, or surgery; 6. At least 6 weeks since prior treatment with nitrosoureas or mitomycin C; 7. Adequate major organ function, with laboratory values within 14 days prior to randomization meeting the following criteria: (1) Hematology: hemoglobin >=90 g/L (without transfusion within 14 days); absolute neutrophil count >1.5 x 10^9/L; platelet count >=80 x 10^9/L; (2) Biochemistry: total bilirubin =60 mL/min (Cockcroft-Gault formula); (3) Cardiac function: left ventricular ejection fraction (LVEF) >=50% by Doppler echocardiography; 8. Written informed consent: (1) Participants must sign an EC-approved written informed consent form in accordance with regulatory and institutional guidelines, dated prior to any protocol-related procedures not part of routine medical care; (2) Participants must be willing and able to comply with the scheduled visits, treatment regimen, laboratory assessments, and other study requirements.
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 supraventricular or ventricular arrhythmias requiring treatment or intervention; 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 (Such as, but not limited to: uveitis, colitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism; Subjects with vitiligo or a history of childhood asthma that has completely resolved and requires no intervention in adulthood may be enrolled; however, subjects with asthma requiring bronchodilator therapy are excluded.); 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 PAN-NeoVax or any excipient; history of severe allergic reactions to any drug, food, or vaccine (including anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, Arthus reaction); 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
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of PAN-NeoVax treatment, including objective response rate (ORR) and disease control rate (DCR);Time to first response (TFR) following PAN-NeoVax treatment, defined as the time from the first dose to the first confirmed complete response (CR) or partial response (PR);To evaluate the duration of response (DOR);To evaluate the duration of stable disease (SD);To evaluate progression-free survival (PFS);To evaluate overall survival (OS); | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate the incidence of dose-limiting toxicities (DLTs) during the first treatment cycle of PAN-NeoVax administration;Number of treatment interruptions due to treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactXingchen Peng
West China Hospital, Sichuan University
Outcome results
None listed