Advanced solid tumors
Conditions
Interventions
Treatment Group:neoantigen-based mRNA personalized cancer vaccine
Sponsors
Shanghai Sixth People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years and =1.0×10^9/L, Platelets (PLT) >= 75×10^9/L, Hemoglobin (Hb) >= 80g/L; 6.Hepatic function: Total Bilirubin (TBIL) 1.5×ULN) > 45ml/min/1.73m^2 (calculated according to the Cockcroft-Gault formula); 11.Coagulation function: Activated Partial Thromboplastin Time (APTT) <= 1.5×ULN; 12.International Normalized Ratio (INR) <= 1.5×ULN; 13.Ability to provide sufficient tumor materials from formalin-fixed paraffin-embedded (FFPE) blocks or sections, or sequencing data obtained within 6 months before the start of the trial; 14.At least 10 tumor neoantigens identified in the provided tumor samples; 15.Eligible patients of childbearing potential (both male and female) must agree to use reliable contraceptive methods (hormonal, barrier, abstinence, etc.) with their partners during the trial and for at least 12 weeks after the last dose of study drug; 16.female patients of childbearing age must have a negative urine pregnancy test within 7 days before the first administration of the study drug.
Exclusion criteria
Exclusion criteria: 1.Patients with uncontrolled comorbidities; 2.Patients who have experienced cerebrovascular accidents (excluding lacunar infarction, minor cerebral ischemia, transient ischemic attack, etc.), myocardial infarction, unstable angina pectoris, or poorly controlled arrhythmias (including QTc interval >= 450 ms in males and >= 470 ms in females) (QTc interval calculated by the Fridericia formula) within 6 months before the first administration of the study drug; 3.Patients with New York Heart Association (NYHA) Class III or IV heart failure according to the NYHA classification, or left ventricular ejection fraction (LVEF) 10 mg/day prednisone or an equivalent dose of similar drugs) or other immunosuppressive therapy within 14 days before the first administration of the study drug or during the study period. However, enrollment is allowed in the following cases: inhalation or topical application of steroids, or adrenal hormone replacement therapy with a dose = 10 mg/day prednisone equivalent, in the absence of active autoimmune diseases; 9.Patients who are still receiving treatment with any other investigational drugs at the time of screening; 10.Patients with hypersensitivity or intolerance to the active pharmaceutical ingredients or excipients of the study drug; 11.Patients with any active infection requiring systemic treatment; 12.Patients with newly developed metastatic lesions during screening or while receiving standard treatment; 13.Patients with positive hepatitis B serological test results indicating active hepatitis B infection; 14.Patients with active hepatitis C virus (HCV) infection; 15.Patients with human immunodeficiency virus (HIV) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-Limiting Toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of relief;Peripheral blood immunogenicity;Objective Response Rate;Progression-free survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactHu Haiyan
Shanghai Sixth People’s Hospital
Outcome results
None listed