AK129 Combination Therapy for Advanced Solid Tumors

Prior treatment

• Has known allergy to any component of any investigational drug; a known history of severe hypersensitivity to other monoclonal antibodies;

Other illness

• Has an active autoimmune disease that has required systemic treatment in the past 2 years;
• 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;
• Past or currently has non-infectious pneumonia/interstitial lung disease that requires systemic glucocorticoid therapy;
• Had a history of myocarditis, cardiomyopathy, and malignant arrhythmia;

Lab values

• 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;

Other

• 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;
• Participating in another clinical research;
• Has known active central nervous system (CNS) metastases, brain stem/meningeal metastasis, spinal cord metastasis or compression;
• Has pleural effusion, pericardial effusion, or ascites that have clinical symptoms or require repeated drainage;
• Pregnant or lactating female.

• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);
• ≥18 years old and ≤ 75 years (regardless of sex);
• ECOG performance status 0-1;
• Life expectancy longer than 3 months;
• 1)Histologically or cytologically confirmed diagnosis of Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer \[AJCC\]); 2)No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of locally advanced or metastatic disease and progressed during or after receiving prior therapy;
• 1)Histologically or cytologically confirmed diagnosis of recurrent or metastatic HNSCC (American Joint Committee on Cancer \[AJCC\]); 2)No prior systemic anti-tumor therapy for recurrent or metastatic HNSCC ;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of recurrent or metastatic disease and progressed during or after receiving prior therapy;
• Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite stabilization;
• Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
• Adequate organ function.