NCT06740019招募中1 期
A Phase Ib, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
Jemincare1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月28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
- 1
- 主要终点
- AEs or SAEs
研究概览
简要总结
A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant voluntarily joined the study, signed an informed consent form, and had good compliance.
- •Age ≥ 18 years and ≤ 75 years old, regardless of gender.
- •Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
- •Malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage.
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0 to
- •Life expectancy of at least 3 months.
- •Adequate organ function.
- •Female participants of childbearing potential should agree to use contraception to prevent pregnancy until 6 months after discontinuation of JMKX
- •The serum pregnancy test result should be negative 7 days before enrollment and must be a non-lactating participant. Male participants must agree to use effective contraception during the study and for 6 months after discontinuation of JMKX000197.
排除标准
- •Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
- •Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.
- •Have used interferon gene stimulating factor (STING) agonists for pleural perfusion。
- •Known allergies to the study drug or its excipient components.
- •Have participated in other clinical trials within 28 days prior to randomization.
- •Major surgery within 28 days prior to randomization.
- •Central nervous system metastatic disease, leptomeningeal disease, or cord compression.
- •Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases.
- •Uncontrollable systemic infections (viruses, bacteria, fungi), including but not limited to positive HBsAg and HBV DNA, positive HCV RNA, positive HIV antibody test or combined infections within the first 28 days of randomization and require systemic anti-infective treatment.
- •Have a history of organ transplantation.
- •Any further condition which, in the opinion of the Investigator, the participant is not suitable in the present study.
研究组 & 干预措施
Arm A
Experimental
JMKX000197 Dose 1
干预措施: JMKX000197 (Drug)
Arm B
Experimental
JMKX000197 Dose 2
干预措施: JMKX000197 (Drug)
Arm C
Other
Tube thoracostomy drainage
干预措施: Tube thoracostomy drainage (Procedure)
结局指标
主要结局
AEs or SAEs
时间窗: Up to approximately 36 days
Recommended Phase II dose (RP2D)
时间窗: Up to approximately 24 months
次要结局
- Puncture /drainage-Free Survival (PuFS)(Up to approximately 24 months)
- Pleural effusion overall response (ORR)(Up to approximately 24 months)
- Overall survival (OS)(Up to approximately 24 months)
- Pharmacokinetics (Cmax)(Up to approximately 7 days)
- Pharmacokinetics(Tmax)(Up to approximately 7 days)
- Pharmacokinetics (t1/2)(Up to approximately 7 days)
- Pharmacokinetics (AUC0-inf)(Up to approximately 7 days)
- Pharmacokinetics (AUC0-t)(Up to approximately 7 days)
- Amount of Drug Excreted Via Urine and Excrement(Up to approximately 48 hours)
研究者
研究点 (1)
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