| Eligibility |
Inclusion Criteria:
1. Age 18~75 (including 18 and 75 years old), gender is not limited;
2. Pathologically confirmed metastatic or locally advanced solid tumors with failure or
absence of standard care;
3. ECOG physical status score must be 0~1;
4. Expected survival of subjects evaluated by the investigator =3 months;
5. Hemogram: absolute neutrophil count (ANC) =1.5×109/L, hemoglobin =90g/L (no red blood
cells were injected within 14 days before the first administration), platelet
=90×109/L;
6. Liver: bilirubin =1.5 times the upper limit of normal value, aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 times the upper limit
of normal value;If the subject has liver metastasis, ALT and AST are allowed to be
less than 5 times the upper limit of normal value;
7. Kidney: Serum creatinine =1.5 times the upper limit of normal value or creatinine
clearance = 60 mL/min (using standard Cockcroft-Gault formula);
8. Understand and voluntarily sign written informed consent.
Exclusion Criteria:
1. Have received chemotherapy, radiotherapy (local palliative radiotherapy for 14 days)
and immunotherapy within 28 days before the first administration, and have received
small molecule targeted drugs or Chinese patent drugs with anti-tumor indications
within 14 days;
2. Major surgery (except diagnostic biopsy) within 28 days prior to the first dose;
3. Subjects with central nervous system (CNS) metastases causing clinical symptoms or
requiring therapeutic intervention;Patients who had previously received BMs were
included if they were asymptomatic =4 weeks prior to initial dosing, had stable
disease on radiographic findings, and did not require corticosteroid or anticonvulsant
therapy;
4. Receive any organ transplantation, including allogeneic stem cell transplantation,
except those that do not require immunosuppression (e.g. cornea transplantation, hair
transplantation);
5. Adverse events caused by previous antitumor therapy have not recovered (i.e., grade 1
or at baseline), except for hair loss and grade 2 neuropathy, hormone replacement
hypothyroidism, or other confirmed chronic adverse events;
6. Subjects with a history of malignancy (non-study tumor) within 3 years prior to the
first study administration date (other than skin squamous cell carcinoma and basal
cell carcinoma, carcinoma in situ of the cervix or breast, or other non-invasive
lesions that the Investigator and Sponsor agree have been cured and have a very low
risk of recurrence within 3 years);
7. Have a known allergy, hypersensitivity or intolerance to corticosteroids, monoclonal
antibodies or human proteins or their excipients;
8. Uncontrolled active infection (CTCAE=2);
9. Subjects with severe respiratory diseases judged by the researcher to be unsuitable
for inclusion;
10. Subjects with a history of serious cardiovascular disease, including previous coronary
artery bypass grafting or stent implantation, myocardial infarction or cerebrovascular
accident within 6 months, history of congestive heart failure or unstable angina
pectoris, uncontrolled severe hypertension, and arrhythmias requiring medication;
11. Active autoimmune diseases (such as inflammatory bowel disease, idiopathic
thrombocytopenic purpura, lupus erythematosus (sle), hemolytic anemia, scleroderma,
severe psoriasis, rheumatoid arthritis, etc.), into the group when the disease is in
stable except ZhuangTaiZhe (no need to systemic immune inhibitors to treat symptoms
stable under the condition of more than 6 months).
12. Subjects with uncontrolled metabolic diseases such as diabetes, severe
gastrointestinal bleeding, and severe diarrhea (CTCAE=2), and subjects with severe
gastrointestinal obstruction requiring intervention;
13. Human immunodeficiency virus (HIV) antibody positive, hepatitis B virus (HBV) surface
antigen positive and HBV DNA test indicated active hepatitis B (HBV-DNA=1000cps/ml),
active hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the
detection limit of the analysis method), active syphilis;
14. Those who received live (attenuated) virus vaccine within 4 weeks before the first
administration;
15. Pregnant or lactating women or men or women who have a birth plan within 12 months;
16. Have a clear history of neurological or psychiatric disorders, including epilepsy or
dementia;
17. Subjects with poor compliance or who are considered by the Investigator to be
unsuitable for participation in this clinical trial.
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