The IIT Study of Evaluation of P-IL-2 Single Agent and With Anti-PD-1

Exclusion Criteria

• •1. Past or present suffering from other types of malignant tumors.
• •2. Known to be allergic to research drugs or any of their excipients, or to be too strict with other monoclonal antibodies.Severe anaphylaxis (NCI-CTCAE 5.0 grade ≥ 3).
• •3. People have hemorrhagic diseases or have hemorrhagic tendencies.
• •4. Received any of the following treatments or drugs before the first study:
• •* large surgery or severe trauma occurred within 4 weeks before the first study of drug treatment.
• •* previous use of immunosuppressive drugs within 2 months prior to the first study, excluding nasal spray.
• •* And inhaled corticosteroids or physiological doses of systemic steroids.
• •* to study the Chinese medicine therapy with anti-tumor indications within 2 weeks before drug treatment for the first time.
• •5. Patients with a history of central nervous system metastasis (non-tumor meningeal metastasis) or spinal cord compression can be enrolled in the study if they have clearly received treatment and have stopped taking anticonvulsants and steroids for 4 weeks or more and have stable clinical manifestations before the first administration of the study.
• •6. Symptomatic, visceral spread, and short-term risk of life-threatening complications. the patients who underwent puncture and drainage within 3 weeks before the first administration included pleural effusion and abdominal cavity. Patients with effusion and pericardial effusion.
• •7. Subjects with active, or history of autoimmune diseases that may recur, or patients at high risk. subjects with the following diseases are allowed to join the group:
• •* stable type I diabetic patients treated with fixed dose of insulin.
• •* autoimmune hypothyroidism which only needs hormone replacement therapy.
• •* skin diseases that do not require systemic treatment.
• •* cured childhood asthma / allergy adult patients without any intervention.
• •8. Within 6 months before screening, any cardiovascular disease met any of the following criteria:
• •* congestive heart failure with heart function ≥ New York Heart Association (NYHA) Class II; left ventricular ejection. Blood fraction (LVEF) \< 50%.
• •* severe arrhythmias requiring drug treatment.
• •* QTcF (Fridericia formula) male \> 450ms, female \> 470ms, or exist risk factors of apical torsion ventricular tachycardia are of clinical significance .
• •* myocardial infarction and severe / unstable angina pectoris occurred within 6 months before administration.
• •* history of thromboembolism with grade 3 or more in the past 2 years, or is being received because of a high risk of thrombosis.
• •Receive thrombolytic or anticoagulant therapy.
• •9. Currently suffering from sudden lung disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, etc., except local interstitial pneumonia caused by radiotherapy.
• •10. Uncontrolled systemic diseases .
• •11. history of human immunodeficiency virus infection, or suffer from other acquired, congenital immunodeficiency. Disease, or a history of organ transplantation, or a history of stem cell transplantation;
• •12. Evidence of active infection.
• •13. Previous history of neurological or mental disorders, or known history of psychotropic substance abuse and alcoholism.
• •History or history of drug use.
• •14. Received any research drug within 4 weeks before the first administration, or participated in another clinical trial at the same time.
• •15. Female patients who are pregnant or lactating, or whose baseline pregnancy test results are positive.
• •16. The researchers believe that it is not suitable for patients to be included in this study.