A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Antitumor Activity of IL - 22BP in Refractory Malignant Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Number of Participants with DLT and Treatment-Related Adverse Event
研究概览
简要总结
This study aims to investigate the safety and efficacy of the IL-22BP in patients with refractory malignant solid tumors.
详细描述
Cancer is a leading global cause of death, with advanced cases posing significant treatment challenges due to low efficacy and severe side effects. Gene therapy, especially mRNA-based immunogene therapy, offers promise. IL-22 promotes tumor progression, and its antagonist, IL-22BP, can inhibit tumor growth.
Patients with refractory, metastatic solid tumors unresponsive to second-line therapy lack viable options. This study aims to establish a novel IL-22BP-based mRNA treatment for advanced cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients: aged ≥ 18 years old and ≤ 70 years old;
- •Patients with histopathologically confirmed, refractory to second-line treatment, advanced recurrent/metastatic malignant solid tumors and without standard clinical treatment regimens (such as patients with advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, malignant melanoma, etc.);
- •Eastern Cooperative Oncology Group (ECOG) performance status score: 0 - 1;
- •Expected survival time ≥ 3 months;
- •More than 28 days since the last chemotherapy/radiotherapy/surgery;
- •More than 6 weeks since the last use of nitrosoureas or mitomycin C;
- •Main organ functions are in good condition;
- •Sign a written informed consent form.
排除标准
- •Have participated in other drug clinical trials within 4 weeks;
- •The tumor is located close to major blood vessels or the trachea;
- •Patients with uncontrolled cardiac clinical symptoms or diseases, such as heart failure of NYHA class II or above, unstable angina pectoris, having had a myocardial infarction within 1 year, and having clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention.
- •For female subjects: pregnant or lactating women.
- •Patients have active tuberculosis, bacterial or fungal infections (≥ grade 2 of NCI-CTCAE 5.0); have active HIV infection, active HBV infection, or HCV infection.
- •Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders;
- •Subjects have any active autoimmune diseases or a history of autoimmune diseases (such as, but not limited to: uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or those whose asthma in childhood has been completely relieved and who do not require any intervention in adulthood can be included; subjects with asthma that requires bronchodilators for medical intervention cannot be included).
- •Subjects are currently receiving immunosuppressive treatment.
- •Have a history of drug abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug use.
- •Known to be allergic, hypersensitive, or intolerant to the studied IL-22BP (including any excipients). Have a severe allergy history to any drugs, foods, or vaccines in the past, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrotizing reaction (Arthus reaction), etc.
- •From the screening period to 12 months after the completion of drug injection, female subjects have pregnancy plans or the partners of male subjects have pregnancy plans.
- •According to the investigator's judgment, there are concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study.
研究组 & 干预措施
Treatment Cohort
In this study, three patients were grouped together. Subsequently, doses of 25 μg and 50 μg of the IL-22BP were administered to them respectively. The treatment will be administered by intratumoral injection. Enrolled subjects will receive inoculations of IL22BP injection according to their respective dose groups, which include 5 doses for basic immunization. During the basic immunization, the first 4 doses will be given at an interval of 1 week each, and the 5th dose will be inoculated 1 month after the 4th dose.
干预措施: IL-22BP (Biological)
结局指标
主要结局
Number of Participants with DLT and Treatment-Related Adverse Event
时间窗: Participation in the whole process of the study. The time window was typically 2 months.
Evaluate the incidence of dose-limiting toxicity during the treatment with IL-22BP formulation and the treatment-related adverse reactions.
Safety
时间窗: Participation in the whole process of the study. The time window was typically 2 months.
Evaluate the incidence of dose-limiting toxicity during the treatment with IL-22BP formulation and the number of treatment interruptions due to treatment-related adverse reactions during the first treatment cycle.
次要结局
- Progression - Free Survival(PFS)(From the time when the patients were enrolled in the study until three months after the last dose of the IL-22BP was injected. The time window was typically 6 months.)
- Overall Survival(OS)(From the time when the patients were enrolled in the study until six months after the last dose of the IL-22BP was injected. The time window was typically 8 months.)
- Objective Response Rate(From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP was injected.The time window was typically 2 months.)
- Disease Control Rate(From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP was injected.The time window was typically 2 months.)
- Time to first complete remission, partial remission on treatment with IL-22BP preparation.(From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP was injected.The time window was typically 2 months.)
- Duration of Response(From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP was injected.The time window was typically 2 months.)
- Progression - Free Survival(PFS)(From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP was injected. The time window was typically 2 months.)
- Overall Survival(OS)(From the time when the patients were enrolled in the study until one month after the last dose of the IL-22BP was injected. The time window was typically 2 months.)
研究者
Xingchen Peng
PhD, Professor
West China Hospital