Advanced Solid Tumors
Conditions
Interventions
Single drug research:RNA vaccine injection
Combined administration:Navuliumab
Sponsors
The First Affiliated Hospital Bengbu Medical College REC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient is at least 18 years old with no gender limitation; 2. Patients with advanced malignant solid tumors confirmed by histopathology or cytology and failed to receive standard treatment or without standard treatment; 3. Identification of at least one KRAS mutation: G12C, G12D or G12V; 4. The subtype was identified as HLA-A11:01 or C08:02; 5. Have at least one measurable lesion according to RECIST V1.1; 6. ECOG PS score was 0-2 in the Eastern Oncology Group; 7. Full organ and bone marrow function, as defined below: 8. Sign written informed consent and be able to comply with the visits and related procedures specified in the program; 9. Eligible fertile patients (male and female) must agree to use a reliable contraceptive method (hormonal or barrier methods or abstinence) during the study period;
Exclusion criteria
Exclusion criteria: 1. A history of severe allergy to biological products; 2. Those in pregnancy or lactation; 3. The expected survival time is less than 3 months; 4. Those who have undergone major surgery within 4 weeks prior to signing the informed consent, or who plan to undergo major surgery during the study period; 5. Received chemotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor drugs within 2 weeks before the first administration; 6. Participating in other clinical studies; 7. Patients with central nervous system metastasis or a history of central nervous system metastasis; 8. Adverse effects of previous antitumor therapy have not recovered to NCI CTCAE V5.0 rating 150mmHg, diastolic blood pressure > 90mmHg); 10. Patients with active ulcers and gastrointestinal bleeding; 11. Patients with uncontrollable pleural effusion, abdominal effusion and pericardial effusion; 12. Active infection requiring treatment; 13.HIV, HCV, syphilis, CMV, EBV infected patients; Patients with active HBV replication (DNA > 500 CPS /mL); 14. A history of interstitial lung disease; 15. The patient has an autoimmune disease or is in an immunosuppressed state; Current systemic steroid use (except recent or current inhaled steroid use); 16. Other conditions that the investigator assessed as ineligible for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate, ORR;Disease Control Rate, DCR;progression-free survival, PFS;Overall Survival,OS;immunoreactivity; | — |
Countries
China
Contacts
Public ContactWangzishu
First Affiliated Hospital Bengbu Medical College
Outcome results
None listed