| Eligibility |
Inclusion Criteria:
1. Male or female, aged = 18 years;
2. Patients with histologically or cytologically confirmed solid tumors who have failed
standard of care or have no standard of care;
3. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;
4. Have life expectancy of at least 3 months based on investigator's judgement;
5. Organ function levels must meet the following requirements:
A:Hematology: absolute neutrophil count (ANC) = 1.5 × 10^9/L, platelet count = 100 x
10^9/L, hemoglobin (Hb) = 100 g/L ; B:Liver: serum total bilirubin (TBIL) = 1.5 × the
upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) = 3 × ULN (patients with primary liver cancer or liver
metastases: AST and/or ALT < 5 × ULN); C:Kidney: creatinine clearance (CrCL) = 50
mL/min;
6. International normalized ratio (INR) = 1.5 × ULN, prothrombin time (PT) = 1.5 × ULN,
activated partial thromboplastin time (aPTT) = 1.5 × ULN;
7. All women of reproductive potential, men whose partner is a woman of reproductive
potential, or their spouses should use adequate barrier contraception throughout the
study and for 3 months after the last dose;
8. Voluntary and agree to sign the informed consent and follow the study treatment
protocol as well as follow-up plan.
Exclusion Criteria:
1. Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded;
2. Patients with any other malignancy within the past 5 years or currently, except for
completely cured non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal
carcinoma in situ of the breast;
3. Received other anti-tumor therapies (such as chemotherapy, radiotherapy, surgery,
endocrine therapy, targeted therapy, immunotherapy, etc.) within 4 weeks or 5
half-lives (whichever is longer) before the first dose, or received modern Chinese
medicine preparations with anti-tumor effect approved by NMPA within 2 weeks prior to
the first dose;
4. Major surgery (excluding vascular access establishment surgery) was received within 4
weeks prior to the first dose;
5. Has received immunosuppressive therapy within 4 weeks prior to the first dose.
However, enrollment is permitted under the following circumstances:
6. In the absence of active autoimmune disease, patients are allowed to receive inhaled
or topical glucocorticoids, or other glucocorticoids at doses = 10 mg/day prednisone
equivalent.
Patients with primary central nervous system (CNS) tumors, or symptomatic CNS tumors,
or spinal cord compression, or carcinomatous meningitis; with the following
exceptions:
Patients with asymptomatic brain metastases (i.e., no progressive central nervous
system symptoms due to brain metastatic sites, no need for corticosteroids, and lesion
size = 1.5 cm); Patients whose symptoms are controlled by treatment, i.e., their
condition is stable and asymptomatic at least 4 weeks after treatment;
7. Use of any other study drug within 4 weeks prior to the first dose, or participation
in other clinical studies;
8. Have received live or attenuated vaccines within 4 weeks prior to the first dose;
9. Patients with known severe allergic reactions (= Grade 3) to the active ingredient and
excipients of the investigational drug, other monoclonal antibodies or
"Immuno-oncology drugs;
10. Toxic and side effects caused by prior anti-tumor therapy before the first dose did
not recover to = Grade 1 (CTCAE v5.0), except for alopecia and sensory neuropathy
below Grade 2;
11. History of interstitial pneumonia or non-infectious pneumonitis requiring
corticosteroids, except for radiation therapy, or current presence of interstitial
pneumonia or non-infectious pneumonitis;
12. = Grade 2 immune-related pneumonitis occurred during prior immunotherapy;
13. History of = Grade 3 immune-related adverse reactions or any adverse reactions leading
to discontinuation of immunotherapy during prior immunotherapy;
14. Past or existing active tuberculosis ;
15. Patients with active auto-immune disease, history of auto-immune disease requiring
systemic therapy, or history of auto-immune disease within 2 years prior to the first
dose, with the following exceptions: leucoderma, childhood asthma/specific reactions,
type I diabetes mellitus, hypothyroidism which can be treated with replacement
therapy;
16. Clinically uncontrollable disease, including, but not limited to, severe diabetes
(fasting glucose > 250 mg/dl,1 mg/dl = 18 mmol/L), uncontrollable hypertension
(systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg), or other
serious disease requiring systemic treatment;
17. Patients with active infections, including active hepatitis B, active hepatitis C, and
human immunodeficiency virus infection;
18. Patients with active infection requiring intravenous infusion;
19. Serious cardiovascular and cerebrovascular diseases, such as cerebrovascular rupture,
stroke, myocardial infarction, unstable angina pectoris, congestive heart failure (New
York Heart Association Grade = II), severe uncontrolled arrhythmia, etc., occurred
within 6 months prior to the first dose;
20. Patients with clinically significant ECG abnormalities: QTcF = 470 msec (corrected by
Fridericia), or having history of congenital long QT syndrome, or taking any known QTc
prolonging medication;
21. Patients who have received allogeneic bone marrow transplant or organ transplant;
22. Known psychiatric disorders, drug abuse, drug use, or alcohol dependence that may
affect trial compliance;
23. Other conditions that were considered not suitable for the study by the investigator.
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