An Open-blind Dose Escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing dose-limiting toxicities (DLTs)
研究概览
简要总结
Based on the activation and regulation of immune system by cytokines, mRNA encoding cytokines has become one of the important directions of mRNA tumor drug development. This product (ABOD2011) is a new generation mRNA product for intratumoral injection.
The primary objective of this study is to assess the safety and tolerability, of ABOD2011 in patients with advanced solid tumors that progressed after standard systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older.
- •Understand and voluntarily sign the informed consent form (ICF).
- •Histopathologically confirmed recurrent or metastatic solid tumors.
- •Failure of prior systemic standard of care, or intolerance to severe toxicity, or lack of standard of care.
- •Presence of at least one measurable lesion as assessed by RECIST Version 1.
- •At least one superficial or deep lesion for intratumoral administration and biopsy.
- •Sufficient organ functions.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Weight > 30 kg.
- •Expected survival longer than 12 weeks.
- •Evidence of menopause in female patients, or for women of childbearing potential: negative for urine or blood pregnancy.
排除标准
- •Any systemic anti-tumor therapy, within 28 days prior to the first dose.
- •Radiotherapy within 14 days prior to first dose.
- •Use of immunosuppressants.
- •Major surgery within 28 days.
- •Inadequately controlled diseases.
- •Active autoimmune and inflammatory diseases.
- •Clinically symptomatic central nervous system tumors or metastases.
- •Toxicity of prior anti-tumor therapy is still NCI-CTCAE ≥
- •Other malignancies within the previous 5 years with the exception of cured basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the breast, and carcinoma in situ of the cervix.
- •Active infections.
- •Other conditions that may increase the risk associated with the study drug, or affect the study compliance, etc., which, in the opinion of the investigator, are not suitable for participation in the study.
研究组 & 干预措施
Human single chain IL-12 mRNA-single dose
Human single chain IL-12 mRNA-single dose
干预措施: human single chain IL-12 mRNA-single dose (Biological)
Human single chain IL-12 mRNA-multiple dose
Human single chain IL-12 mRNA-multiple dose
干预措施: human single chain IL-12 mRNA-multiple dose (Biological)
结局指标
主要结局
Number of Participants Experiencing dose-limiting toxicities (DLTs)
时间窗: From first dose to Day 28
Number of Participants Experiencing dose-limiting toxicities (DLTs)
Number of Participants Experiencing Adverse Events (AEs)
时间窗: From signed ICF until the date of last visit or start new antitumor therapy, whichever comes first, assessed up to 36 months
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants Experiencing Severe Adverse Events (SAEs)
时间窗: From signed ICF until the date of last visit or start new antitumor therapy, whichever came first, assessed up to 24 months
Number of Participants Experiencing Severe Adverse Events (SAEs)
次要结局
- Maximum observed concentration (Cmax) of ABOD2011(From first dose of ABOD2011 through to 28 days after last dose of investigational product)
- Area under the concentration-time curve (AUC) of ABOD2011(From first dose of ABOD2011 through to 28 days after last dose of investigational product)
- Maximum observed concentration (Cmax) of IL-12(From first dose of ABOD2011 through to 28 days after last dose of investigational product)
- Area under the concentration-time curve (AUC) of IL-12(From first dose of ABOD2011 through to 28 days after last dose of investigational product.)
- Plasma concentration of IFN gamma(From first dose of ABOD2011 through to 28 days after last dose of investigational product.)
- Progression-Free Survival (PFS)(Up to 36 months)
- Overall Survival(Up to 36 months)
- Overall Response Rate (ORR)(Up to 36 months)
- Disease Control Rate(DCR)(Up to 36 months)
- Duration of Response (DOR)(Up to 36 months)