AK129 Combination Therapy for Advanced Solid Tumors

Exclusion Criteria

• •1. Histologically or cytologically confirmed the presence of small cell carcinoma components/EGFR-sensitive mutations or ALK fusion positivite/known ROS1 rearrangement, MET exon 14 skipping mutation, EGFR exon 20 insertion mutation, BRAF V600E mutation, NTRK gene fusion positivite or RET gene fusion positivite;
• •2. Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite highly unstable/mismatch repair gene expression defect (MSI-H/dMMR)or histopathological examination confirmed other pathological types;
• •3. Participating in another clinical research;
• •4. Has known active central nervous system (CNS) metastases, brain stem/meningeal metastasis, spinal cord metastasis or compression;
• •5. Has an active autoimmune disease that has required systemic treatment in the past 2 years;
• •6. Has known active tuberculosis (TB) and suspected active TB should be ruled out by clinical examination; known active syphilis infection; known active Hepatitis B or Hepatitis C;
• •7. Past or currently has non-infectious pneumonia/interstitial lung disease that requires systemic glucocorticoid therapy;
• •8. Has pleural effusion, pericardial effusion, or ascites that have clinical symptoms or require repeated drainage;
• •9. Had a history of myocarditis, cardiomyopathy, and malignant arrhythmia;
• •10. Has known allergy to any component of any investigational drug; a known history of severe hypersensitivity to other monoclonal antibodies;
• •11. Pregnant or lactating female.