Phase I Clinical Study of SHR-5495 in the Treatment of Patients With Advanced Malignant Tumors

Inclusion Criteria:

1. Age range from 18 to 70 years old (including 18 and 70 years old), both male andfemale
2. Pathologically confirmed advanced malignant tumors that have failed sufficientstandard treatment or have no effective standard treatment plan
3. ECOG score: 0-1
4. Expected survival time ≥ 12 weeks
5. Existence of measurable lesions that meet RECIST 1.1 standards
6. Sufficient Hematology and end organ function shall be completed within 7 days beforethe first study treatment
7. Left ventricular Ejection fraction (LVEF) ≥ 50% within 28 days before the firstadministration
8. Women of childbearing age must carry out serum Pregnancy test within 7 days before thefirst administration, and the result is negative. Female subjects of childbearing ageand male subjects with partners of childbearing age must agree to use efficientmethods of contraception or abstinence within at least 26 weeks (female subjects) or 14 weeks (male subjects) from the date of signing the informed consent form until thelast administration
9. The patient voluntarily joined this study, signed an informed consent form, had goodunderstand the research procedures, and have signed informed consent

Exclusion Criteria:

1. Has received treatment with interleukin
2. Previously received immune checkpoint inhibitors
3. Central nervous system metastasis with clinical symptoms in patients
4. The third space effusion with clinical symptoms needs repeated drainage, such aspericardial effusion, Pleural effusion and peritoneal effusion that cannot becontrolled after pumping or other treatment
5. Subjects who received anti-tumor therapy and systemic immune stimulation therapywithin 4 weeks prior to the first dose of the study drug; Received traditional Chinesepatent medicines and simple preparations anti-tumor treatment within 2 weeks beforethe first dose of study drug
6. Subjects who received>30Gy of non thoracic radical radiation therapy within 28 daysbefore the first medication, those who received>30Gy of chest radiation therapy within 24 weeks before the first medication, and those who received ≤ 30Gy of palliativeradiation therapy within 14 days before the first medication
7. Subjects who have received systemic Immunosuppressive drug treatment within 2 weeksbefore the first administration, or who are expected to require systemicimmunosuppressive drug treatment during the study treatment.
8. Patients who have not recovered to ≤ CTCAE level 1 (CTCAE v5.0) due to adverse eventscaused by previous treatment
9. Having autoimmune diseases
10. Other malignant tumors within 2 years before screening, excluding fully treatedcervical Carcinoma in situ, basal cell or squamous cell skin cancer, local prostatecancer after radical surgery, and ductal Carcinoma in situ after radical surgery
11. Subjects with known or suspected interstitial pneumonia; Other moderate to severe lungdiseases that may interfere with the detection or treatment of drug-related pulmonarytoxicity and seriously affect respiratory function
12. Subjects with severe cardio cerebral Vascular disease
13. Clinically significant bleeding symptoms or tendency to bleed within one month beforethe first administration
14. Arteriovenous thrombotic events that occurred within 3 months before the firstadministration
15. Uncontrolled tumor related pain or symptomatic hypercalcemia. Subjects who requirepainkillers must already have a stable painkillers treatment plan at the time of entryinto the study; Symptomatic lesions suitable for palliative radiotherapy should betreated before entering the study
16. Active hepatitis B or active hepatitis C
17. Abnormal electrocardiogram (ECG) examination, judged by the researcher to haveclinical significance
18. Have a history of immune deficiency
19. Evidence of active tuberculosis infection within 1 year prior to the firstadministration, or a history of active tuberculosis infection more than 1 year agowithout formal treatment
20. Serious infection occurred within 4 weeks before the first administration; Activeinfections that have received therapeutic intravenous or oral antibiotics within 2weeks prior to starting the study.
21. History of live attenuated vaccine administration within 28 days prior to initialadministration or expected study period
22. Within 28 days prior to the first administration, major surgeries other than diagnosisor biopsy have been performed; Traumatic minor surgery experienced within 7 days priorto first administration
23. Subjects who have previously received or are preparing to receive allogeneic bonemarrow transplantation or solid organ transplantation
24. Has a history of severe allergic reactions to other monoclonal antibodies/fusionprotein drugs, and is allergic to any component of the research treatment plan
25. Female subjects during pregnancy, lactation, or planning to conceive during the studyperiod
26. The subject has a known history of psychotropic substance abuse, alcoholism, or drugabuse
27. Researchers believe that any other medical, psychiatric, or social condition mayinterfere with the subjects' rights, safety, health, or ability to sign informedconsent, cooperate and participate in the study, or interfere with the evaluation ofthe study medication