Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, in Patients With Advanced Malignancies

Inclusion Criteria:

1. Provide signed informed consent;
2. Male or female aged at 18-75 (inclusive) years;
3. Expected survival ≥12 weeks;
4. ECOG PS score 0 or 1;
5. Provide archival or fresh tissues for CLDN18.2 expression analysis;
6. Adequate laboratory parameters;
7. Suffer from advanced or metastatic malignant local solid tumors confirmed byhistological diagnosis and meet the criteria of the enrolled group as follows: Ia: The subjects for whom no standard treatment regimens are available or who isintolerable to standard treatments. Ib: pancreatic carcinoma, gastric adenocarcinoma, advanced or metastatic solid tumors

Exclusion Criteria:

1. Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of theinterventional study.
2. Any investigational drugs received within 4 weeks prior to the first study treatment.
3. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose ofstudy therapy.
4. Immunosuppressive drugs were used within 4 weeks prior to the first administration ofthe study drug.
5. Medication requiring long-term systemic hormones or any other immunosuppressiontherapy.
6. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds,ulcers, or fractures were performed within 4 weeks prior to the first dose of studytherapy.
7. There was unrecovered toxicity (excluding hair loss or fatigue) according to NCI CTCAEv5.0 induced by previous antitumor therapy (24 weeks before the first dose of study),and there were unrecovered immune-related adverse events (irAE) associated withimmunotherapy.
8. Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases,or leptomeningeal disease.
9. History of autoimmune disease , present active autoimmune disease or inflammatorydiseases
10. Present or history of pulmonary diseases such as interstitial pneumonia,pneumoconiosis, drug-related pneumonia, pulmonary fibrosis, active pulmonaryinfection, severely impaired pulmonary function.
11. Positive human immunodeficiency virus (HIV) test.
12. Active hepatitis B or C, or tuberculosis.
13. History of allogeneic organ transplantation and allogeneic hematopoietic stem celltransplantation.
14. History of gastrointestinal perforation and/or fistula at 6 months prior to studyinclusion.
15. Hydrothorax, ascites, and pericardial effusion with clinical symptoms requiringdrainage.
16. Known history of hypersensitivity to any components of the IBI389 or Sintilimab.
17. Uncontrolled complications of disease.
18. Other acute or chronic illness, mental illness, or abnormal laboratory test valuesthat may increase the risk of study participation or administration of study drugs, orinterfere with the interpretation of study results.
19. Pregnant or nursing females.