Advanced solid tumor resistant or refractroy to standard therapy
Conditions
Interventions
Test group:SapRNA-MICA/B tumor vaccine injection
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years and gender; 2. Expected survival of more than 12 weeks; 3. Histologically or cytologically confirmed advanced solid tumors; failure of standard therapy (disease progression after treatment or intolerance of treatment) and no effective treatment available, or no standard treatment regimen available, or inaccessible due to objective constraints; 4. At least one measurable lesion according to RECIST v1.1 criteria; 5. Have an Eastern Cooperative Oncology Group (ECOG) Physical Status (PS) score of 0 or 1; 6. Adequate organ and bone marrow function as defined below: Routine blood count: absolute neutrophil count (ANC) = 1.5 x 109/L; platelet count (PLT) = 100 x 109/L; hemoglobin level (HGB) = 9.0 g/dL. granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), erythrocyte transfusions, and platelets have not been used within the 14 days prior to the test. transfusions. 7. Liver Function: Subjects with hepatic metastases: AST and ALT = 5 x ULN and total bilirubin = 1.5 x ULN (Exception: for subjects with Gilbert's syndrome, if direct bilirubin is = 35%, total bilirubin = 3.0 x ULN is allowed). Subjects without liver metastases: AST and ALT = 2.5 x ULN and total bilirubin = 1.5 x ULN (exception: for subjects with Gilbert's syndrome, if direct bilirubin = 35%, total bilirubin = 3.0 x ULN is allowed). 8. Renal function: blood creatinine (Scr) = 1.5 x ULN. 9. Adequate coagulation function, defined as International Normalized Ratio (INR) = 1.5 or Prothrombin Time (PT) = 1.5 x ULN; if the subject is on anticoagulant therapy, it is permitted as long as the PT is within the range formulated by the anticoagulant drug. 10. Echocardiogram (ECHO) or multigated controlled acquisition (MUGA) scan showing left ventricular ejection fraction (LVEF) = 50%. 11. Signed written informed consent and are able to comply with protocol-specified visits and related procedures; 12.Eligible patients (male and female) of childbearing potential must agree to use a reliable method of contraception for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Patients with autoimmune disease or in an immunosuppressed state; requiring systemic corticosteroid (= 10 mg/day prednisone, or equivalent of other corticosteroids) or immunosuppressive therapy within 14 days prior to the first dose; except for inhalation or topical application of hormones, or physiologic replacement doses of hormones due to adrenal insufficiency; 2. Major surgical treatment (e.g., major transabdominal, transthoracic, etc. excluding diagnostic puncture or peripheral vascular access replacement) within 28 days prior to the first dose; 3. other antineoplastic therapy within 28 days prior to the first dose or within 5 half-lives of the previous antineoplastic agent, whichever is shorter; 4. Female patients who are breastfeeding or have a positive serum pregnancy test at the screening visit; 5. any Grade 4 immune-related AE (irAE) on prior immunotherapy (patients with endocrine disorders receiving replacement therapy or presenting with asymptomatic serum amylase or lipase elevations may be enrolled in the study), any irAE on prior immunotherapy that resulted in permanent discontinuation of therapy, or any Grade 3 irAE within = 6 months prior to the start of therapy 6. patients known to have or found to have active CNS metastases and/or carcinomatous meningitis on screening. However, the following subjects are allowed to enroll: 1) Patients with asymptomatic brain metastases (i.e., no progressive CNS symptoms caused by brain metastases that do not require the use of corticosteroids) may be enrolled. 2) Subjects who have been treated and have had stable brain metastatic lesions for at least 2 months, with no evidence of new or enlarging brain metastases. 3) Patients who have been treated and have no evidence of new or enlarging brain metastases; 7. Severe cardiovascular disease: poorly controlled hypertension (systolic blood pressure >160 mmHg, diastolic blood pressure >95 mmHg), symptomatic cardiac insufficiency (NYHA II-IV), unstable angina pectoris or myocardial infarction within 6 months, or the presence of QTc prolongation or risk of tachycardia (baseline QTcF>470 ms, uncorrectable hypokalemia, long QT syndrome, resting state with no evidence of new or expanding brain metastases) despite standard treatment. QT syndrome, atrial fibrillation with a heart rate >100 bpm at rest, or severe cardiac valvular disease); 8. patients with uncontrollable pleural effusion, abdominal effusion, pericardial effusion; 9. Active infections requiring treatment: active HBV or HCV infection; known HIV infection or history of AIDS; active tuberculosis, etc; 10. Toxicity from prior antineoplastic therapy that has not recovered to CTCAE = Grade 1 (NCI-CTCAE v5.0) or baseline levels, except for alopecia and skin hyperpigmentation (any grade allowed); 11. History of severe allergy to biologics; 12.Other conditions that may result in increased risk associated with study medication, or affect trial compliance, etc. that the investigator deems unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity, DLT; | — |
Countries
China
Contacts
Public ContactNing Li
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed