A Phase II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Number of subjects with adverse events (AEs)
研究概览
简要总结
This is an open-label, multi-center phase II clinical study consisting of two parts:
Part I: To evaluate the safety and efficacy of AK130 combined with AK112 in advanced pancreatic cancer.
Part II: To evaluate the safety and efficacy of AK112, either as monotherapy or in combination with AK130, in advanced pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able and willing to provide written informed consent.
- •Have a life expectancy of at least 3 months.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Subjects with histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy.
- •According to RECIST v1.1, there is at least one measurable lesion.
- •Has adequate organ function.
- •All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 90 days after the last dose of study treatment.
- •Able to to comply with all requirements of study participation (including all study procedures).
排除标准
- •Except for PDAC, the subjects had other malignant tumors within the 5 years prior to enrollment.
- •There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.
- •There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
- •Prior systemic therapy with either TGF-β inhibitors or anti-angiogenic agents.
- •There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.
- •History of severe bleeding tendency or coagulation dysfunction.
- •Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
- •Pregnant or lactating female subject.
研究组 & 干预措施
AK112 in combination with AK130
干预措施: AK112 (Drug)
AK112 in combination with AK130
干预措施: AK130 (Drug)
AK112
干预措施: AK112 (Drug)
结局指标
主要结局
Number of subjects with adverse events (AEs)
时间窗: From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy.
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Objective Response Rate (ORR)
时间窗: Through study completion, an average of 2 years
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
次要结局
- Disease control rate (DCR)(Through study completion, an average of 2 years)
- Duration of Response (DoR)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- Time to response (TTR)(From date of randomization until the date of first documented response, assessed up to 24 months.)
- Progression Free Survival (PFS)(Through study completion, an average of 2 years.)
- Overall survival (OS)(Through study completion, an average of 2 years.)