An Exploratory Study to Evaluate Safety and Efficacy of the Neoantigen Personalized mRNA Vaccine AK154 Monotherapy or in Combination With AK104 or AK112,and the Sequential mFOLFIRINOX Regimen as Adjuvant Therapy in Surgically Resectable Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC
详细描述
This is a prospective, open-label, single-center, exploratory clinical study. To explore the safety, tolerability, efficacy, immunogenicity, and PK/PD profile of neoantigen personalized mRNA vaccine AK154 monotherapy or combined with AK104 or AK112, sequential mFOLFIRINOX chemotherapy regimen as postoperative adjuvant therapy in Surgically Resected Pancreatic Adenocarcino
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed the informed consent form and complied with protocols requirements
- •Patients with radiographically resectable primary pancreatic tumors
- •Histopathology or cytology confirmed resected PDAC with macroscopic complete resection (R0 and R1)
- •Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0
- •ECOG 0 or 1
- •Life expectancy ≥ 6 months
- •Surgical complications have recovered,
- •Adequate organ function
- •Patients with fertility are willing to use an adequate method of contraception.
排除标准
- •The presence of other pathologic types
- •Participating in another clinical study
- •Have received treatment for pancreatic cancer, including chemotherapy, radiation therapy, targeted therapy, immunotherapy,etc
- •Plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment
- •Severe infection occurs within 4 weeks prior to the first dose
- •Requiring systemic therapy with glucocorticoids or other immunosuppressive drugs within 14 days prior to initial administration.
- •Acute pancreatitis or subclinical pancreatitis
- •Active autoimmune disease
- •Allergic to immunotherapies and related drugs
- •History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •Splenectomy history
- •Active tuberculosis
- •Known or highly suspected history of interstitial pneumonia.
- •Clinically significant liver disease
- •Uncontrolled or severe cardiovascular disease.
- •Severe bleeding tendency or history of coagulopathy
- •Active malignancy within the last 3 years
- •Active syphilis infection
- •Any other situations that are not suitable for inclusion in this study judged by investigator.
研究组 & 干预措施
Pancreatic Cancer
Resectable PDAC
干预措施: mFOLFORINOX (Drug)
Pancreatic Cancer
Resectable PDAC
干预措施: AK154 (Biological)
Pancreatic Cancer
Resectable PDAC
干预措施: Cadonilimab (Biological)
Pancreatic Cancer
Resectable PDAC
干预措施: Ivonescimab (SMT112 or AK112) Injection (Biological)
结局指标
主要结局
DLT
时间窗: Day 1 to Day 21 after the first tumour vaccine was administrated
Percentage of subjects who meet the criteria of DLT in DLT observation period
AE
时间窗: From ICF up to 30days after last study treatment
Percentage of subjects with Adverse Events (AEs)
次要结局
- RFS(2 years)
- OS(2 years)