A Study of GNC-077 in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer and Other Solid Tumors

Inclusion Criteria

• •1. Able to understand the informed consent form, voluntarily participate in and sign the informed consent form;
• •2. Gender is not limited;
• •3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
• •4. Locally advanced or metastatic non-small cell lung cancer and other solid tumors;
• •5. Must have at least one measurable lesion that meets the RECIST v1.1 definition;
• •6. have archived primary or recurrent tumor tissue specimens that can be submitted for central review;
• •7. ECOG ≤1;
• •8. The expected survival time as judged by the investigators was ≥3 months;
• •9. Bone marrow function, renal function and liver function should meet the requirements;
• •10. Coagulation function: fibrinogen ≥1.5g/L; Activated partial thromboplastin time (APTT) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN;
• •11. Fertile female subjects or male subjects with fertile partners must use highly effective contraception from 7 days before the first dose until 12 weeks after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose;
• •12. Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.
• •5. Patients at risk for active autoimmune disease or with a history of autoimmune disease may have central nervous system involvement;
• •6. Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
• •7. Patients with previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
• •8. Had a history of severe cardiovascular and cerebrovascular diseases;
• •9. Patients had or had thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism within 6 months before screening;
• •10. Brain parenchymal metastases and/or meningeal metastases or spinal cord compression, excluding stable and asymptomatic brain parenchymal metastases;
• •11. Uncontrolled pleural effusion with clinical symptoms who were judged by the investigator to be ineligible for enrollment;
• •12. Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
• •13. Who had participated in a clinical trial of an unmarketed drug within 4 weeks before the trial dose;
• •14. Had received a live vaccine within 4 weeks before the trial dose;
• •15. Other circumstances that the investigator deemed inappropriate for participation in the trial.