| Eligibility |
Inclusion Criteria:
1. Have a full understanding of the study content, process, and possible adverse
reactions before the study, and sign the informed consent form (ICF); voluntarily
participate in the study; be able to complete the study as per protocol requirements;
2. Aged = 18 years and =75 years at the time of signing the ICF;
3. Patients with histologically or cytologically confirmed advanced malignant solid tumor
who have failed or cannot receive the standard treatment;
4. With at least one measurable lesion according to RECIST V1.1 (for solid tumors);
5. Eastern Cooperative Oncology Group (ECOG) performance status score of = 1 at
enrollment;
6. Expected survival > 3 months;
7. Patients with Non-Small Cell Lung Cancer had no EGFR sensitivity mutation or gene
rearrangement or jump of ALK, ROS1, RET and METex14;
8. For patients with hepatocellular carcinoma, Child-Pugh score has to be A;
9. Have appropriate hematological functions: no blood transfusion or Treatment for
hemocytopenia within 14 days before the first administration; absolute neutrophil
count = 1500/µL; haemoglobin = 9 g/dL; platelet count = 90,000/µL;
10. Have appropriate coagulation functions: activated partial thromboplastin time (APTT) =
1.5 × ULN; prothrombin time (PT) = 1.5 × ULN; international normalized ratio (INR) =
1.5 × ULN;
11. Have appropriate liver functions: total bilirubin level = 1.5 × ULN, aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) levels = 2.5 × ULN (AST and
ALT = 5 × ULN for patients with known liver metastasis or primary hepatocellular
carcinoma);
12. Have appropriate renal functions: blood creatinine = 1.5 × ULN or creatinine clearance
= 50 mL/min (calculated by Cockcroft-Gault formula);
13. The first administration of the investigational product must be: at least 28 days
apart from the previous major surgery, medical device treatment, or local
radiotherapy; at least 28 days apart from the previous cytotoxic chemotherapy,
immunotherapy, and biological agent therapy; at least 14 days apart from the previous
hormone therapy and surgical operation; at least 21 days or 5 half-lives apart from
the administration of small molecule targeted drugs, whichever is longer; at least 14
days apart from the traditional Chinese medicine for tumor indications; at least 14
days apart from the endocrine therapy; For any drug with antitumor effect not listed
above, at least 5 half lives shall be separated before administration of the first
study drug;
14. Male and female subjects with child-bearing potential must agree to use at least one
highly effective contraception method during the study and within at least 6 months
after the last administration of the investigational product.
Exclusion Criteria:
1. The adverse reactions (except alopecia and other adverse reactions determined by the
investigator to have no safety risk) of previous anti-tumor therapy have not yet
recovered to = grade 1 (CTCAE V5.0);
2. Those who are known to have severe anaphylaxis (grade 4 or greater in CTCAE V5.0) to
macromolecular protein preparations/monoclonal antibodies or to any component of the
investigational product;
3. Patients with any of the following unstable or poorly controlled diseases:1)Active
systemic infectious diseases requiring intravenous antibiotics within 2 weeks before
the first administration of the investigational product;2)Any poorly-controlled
cardiovascular and cerebrovascular clinical symptoms or diseases, including but not
limited to: (1) NYHA Class II or greater cardiac failure or left ventricular ejection
fraction (LVEF) < 50%; (2) unstable angina pectoris; (3) myocardial infarction and
cerebral infarction within 6 months, (4) clinically significant supraventricular or
ventricular arrhythmia without clinical intervention or poorly controlled after
clinical intervention;3)Other chronic diseases which, in the opinion of the
investigator, may compromise the safety of the patient or the integrity of the study;
4. Assessed as unsuitable for inclusion by the investigator, due to brain metastases,
spinal cord compression, or cancerous meningitis with clinical symptoms, or
uncontrolled brain or spinal cord metastases that have been evidenced;
5. Previous grade 3 or greater irAEs in immunotherapy;
6. Have had other malignant tumors within 5 years before enrollment, except: (a) those
with cured cervical carcinoma in situ or non-melanoma skin cancer; (b) those with
cured second primary cancer without recurrence within 5 years; (c) those with double
primary cancers believed to be able to benefit from this study; (d) those whose
metastasis has been clearly excluded from a certain primary tumor source;
7. those who have received anti-LAG-3 antibody therapy;
8. Have active autoimmune diseases (including but not limited to the following diseases
or syndromes, such as interstitial pneumonia, colitis, hepatitis, hypophysitis,
vasculitis, nephritis, hyperthyroidism, and hypothyroidism), except: vitiligo or cured
childhood asthma/allergy that does not need any intervention in adulthood, autoimmune
mediated hypothyroidism treated with stable dose of thyroid replacement hormone, and
type I diabetes treated with stable dose of insulin; those in a stable condition and
requiring no systemic immunosuppressant therapy (including corticosteroid hormone) are
allowed to be enrolled;
9. Have received systemic corticosteroids (prednisone > 10 mg/d or equivalent dose of
similar drug) or other immunosuppressants within 14 days before the first
administration; Except: patients treated with topical, ocular, intra-articular,
intranasal, and inhaled corticosteroids; those with short term use of corticosteroids
for prophylaxis, such as contrast agents;
10. Patients in pregnancy [confirmed by serum beta-human chorionic gonadotropin (ß-HCG)
test] or breastfeeding;
11. With a history of immunodeficiency, including human immunodeficiency virus
(HIV)-positive or other acquired or congenital immunodeficiencies, or a history of
organ transplantation;
12. Patients with active HBV or HCV infection (HBV DNA = 10*4 copies/mL or positive HCV
RNA, but patients with HBV DNA < 10*4 copies / mL after treatment will be excluded);
Subjects with co-infection of hepatitis B and hepatitis C (HBsAg or HBcAb positive,
and HCV antibody positive);
13. Have received live vaccines within 28 days prior to the first administration;
14. Interstitial pneumonia occurred during previous anti-tumor treatment;
15. Patients whose medical history or any other evidence suggests that participation in
the study may confuse the results, or subjects for whom the investigator believes the
study is not in their best interest;
16. Participating in other clinical studies or less than 14 days from the end of the
treatment of the previous clinical study.
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