A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Chemotherapy as Second Line Therapy in Unresectable Neuroendocrine Neoplasm
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 14
- 主要终点
- Objective Response Rate
研究概览
简要总结
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
PM8002+FOLFIRI
Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.
干预措施: FOLFIRI (Drug)
PM8002+FOLFIRI
Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years.
干预措施: PM8002 (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Up to approximately 2 years
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
Treatment related adverse events (TRAEs)
时间窗: Up to 30 days after last treatment
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
次要结局
- Progression free survival (PFS)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Duration of response (DoR)(Up to approximately 2 years)
- Disease control rate (DCR)(Up to approximately 2 years)