NCT06156267尚未招募早期 1 期
An Exploratory Study of Neoantigen Personalized mRNA Vaccines in Combination With Adebrelimab and Sequential mFOLFIRINOX Regimen in Patients With Surgically Resected Pancreatic Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
This is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mRNA tumour vaccine combined with Adebrelimab (a PD-L1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma.
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 with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (PDAC) with macroscopic complete resection (R0 and R1).
- •Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M
- •Tumour specimen availability.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Life expectancy ≥ 6 months.
- •Surgical complications have recovered, or complications lower than Clavien-Dindo complication grade
- •Adequate marrow and organ function.
- •Patients with fertility are willing to use an adequate method of contraception.
排除标准
- •Prior anti-PDAC therapy (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy and therapeutic tumor vaccines) prior to initiation of study treatment.
- •Unsuitable for immunotherapy assessed by the investigator.
- •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.
- •Have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years.
- •Active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment.
- •Known or highly suspected history of interstitial pneumonia.
- •Allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines.
- •Prior malignancy within 5 years prior to study entry.
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •Known splenectomy history.
- •Concurrent severe infection within 28 days prior to initiation of study treatment.
- •Congenital or acquired immune deficiency.
- •Active hepatitis B (HBV-DNA≥1000IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of assay).
- •Uncontrolled or severe cardiovascular disease.
- •Other situations that are not suitable for inclusion in this study judged by investigator.
研究组 & 干预措施
Part A: Dose Escalation, Part B: Dose Expansion
Experimental
干预措施: Adebrelimab (Drug)
Part A: Dose Escalation, Part B: Dose Expansion
Experimental
干预措施: mRNA tumor vaccines (Drug)
结局指标
主要结局
DLT
时间窗: Day 1 to Day 28 after the first tumour vaccine was administrated
Percentage of subjects who meet the criteria of DLT in DLT observation period
RDE
时间窗: From first dose up to end of the study, assessed up to 36 months
Recommended dose of expansion
AE
时间窗: From date of ICF up to end of the study, assessed up to 36 months
Percentage of subjects with Adverse Events (AEs)
MTD/MAD
时间窗: From first dose up to end of the study, assessed up to 36 months
Maximum tolerated dose (MTD)/Maximum administrated dose (MAD)
次要结局
未报告次要终点
研究者
Xian-Jun Yu
Principal Investigator
Fudan University
研究点 (1)
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