Anti-PD-1 Antibody Alone or in Combination With Decitabine/Chemotherapy in Relapsed or Refractory Malignancies

Prior treatment

• Prior organ allograft.

Other illness

• Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
• Serious uncontrolled medical disorders or active infections, pulmonary and intestinal infection especially.
• Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Other

• Women who are pregnant or breastfeeding.

• Subjects must have histological confirmation of relapsed or refractory malignancies,including Non-Hodgkin'lymphoma, Hodgkin'lymphoma, gastrointestinal cancers, hepatocellular carcinoma, breast cancer, ovarian cancer or lung cancer or renal-cell cancer or pancreatic cancer or bile duct cancer.
• 12 to 75 years of age.
• ECOG performance of less than 2.
• Life expectancy of at least 3 months.
• Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria; with solid tumors must have at least one measureable lesion \>1 cm per RECIST1.1.
• Subjects must have received at least two prior chemotherapy regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
• Subjects must have adequate bone marrow, live, renal, lung and heart functions.
  • Absolute neutrophil count greater than or equal to 1,000/μL.
  • Platelet count greater than or equal to 70,000/µL.
  • Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN).
  • Serum creatinine less than or equal to 1.5 x ULN.
  • Alanine aminotransferase \[ALT or SGPT\] and aspartate aminotransferase \[AST or SGOT\] less than or equal to 2.5 x ULN.