A Study of PM8002 in Combination With Chemotherapy in Patients With NEN

This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET) who failed first-line platinum-based chemotherapy

Inclusion criteria

• Signed informed consent form before any trial-related processes;
• Aged ≥ 18 years;
• Ki-67≥55% G3 NET and NEC were confirmed histologically or cytologically by pathological diagnosis in this study;
• Subjects failed first-line platinum-based chemotherapy;
• Adequate organ function;
• The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
• Expected survival ≥ 12 weeks;
• Had at least one measurable tumor lesion according to RECIST v1.1;

Exclusion criteria

• History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
• Evidence and history of severe bleeding tendency;
• History of severe cardiovascular diseases within 6 months;
• Subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during the screening period (up to 24 months);
• Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
• History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
• History of alcohol abuse, psychotropic substance abuse or drug abuse;
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
• Pregnant or lactating women;
• Other conditions considered unsuitable for this study by the investigator.