NCT05198752招募中1 期
A Phase 1 Clinical Study to Evaluate the Tolerability, Safety,Immunogenicity and Efficacy of the Neoantigen mRNA Personalised Cancer Vaccine SW1115C3 in Patients With Advanced Malignant Solid Tumours
Stemirna Therapeutics3 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2022年3月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- ，Dose-limiting toxicity incidence (participants who experience DLT)
研究概览
简要总结
This is a Phase 1 open label study to evaluate the tolerability, safety, immunogenicity, and efficacy of SW1115C3, a neoantigen mRNA personalised cancer vaccine, in patients with advanced malignant solid tumours.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are 18 to 80 years old (including boundary values), without limitation of sex at time of consent.
- •Based on the RECIST 1.1 criteria for disease progression, (a maximum increase in tumour diameter of 20%) for participants undergoing prescreening who are receiving standard treatment, these participants may reach the defined disease progression criteria at the time of tumour vaccine administration.
排除标准
- •Have used a live attenuated vaccine within 4 weeks before the first use of SW1115C3 with the following exceptions:
- •Adverse reactions induced by previous anti-tumour treatments have not yet recovered to Grade ≤ 1 (except for toxicity evaluated to have no risk of safety by the PI [or designee], such as hair loss, Grade 2 peripheral neurotoxicity and hypothyroidism stabilised by hormone-replacement therapy) based on NCI CTCAE version 5.0.
研究组 & 干预措施
Neoantigen mRNA Personalised Cancer
Experimental
This study is a 3+3 dose escalation design. Participants will receive a total of 6 cycles of SW1115C3 every 21 days.
干预措施: Neoantigen mRNA Personalised Cancer SW1115C3 (Drug)
结局指标
主要结局
，Dose-limiting toxicity incidence (participants who experience DLT)
时间窗: 21 day
次要结局
- Objective response rate(ORR) assessment per RECIST Version 1.1(1 year)
研究者
研究点 (3)
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