NCT07615894尚未招募1 期
A Single-Arm, Open-Label, Prospective Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of WSK-IM02 in Patients With Advanced Solid Tumors Complicated by Malignant Pleural or Peritoneal Effusions
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 9
- 试验地点
- 1
研究概览
简要总结
This is a prospective, single-center, interventional, phase I, dose-escalation, single-arm study designed to evaluate the safety, tolerability, and preliminary efficacy of intrapleural/intraperitoneal infusion of WSK-IM02 in patients with advanced solid tumors complicated by malignant pleural or peritoneal effusions who have failed standard of care.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤75 years.
- •Voluntarily sign informed consent form.
- •Patients with histologically or cytologically confirmed advanced solid tumors.
- •Histologically or cytologically confirmed malignant pleural/peritoneal effusion requiring drainage; or, in the absence of histologic/cytologic evidence, pleural effusion with clear imaging evidence of malignant pleural/peritoneal lesions on chest/abdominal CT and diagnosed as malignant pleural/peritoneal tumor in clinical practice.
- •Have received standard systemic therapy and developed clinical symptoms of serous cavity metastasis.
- •ECOG performance status: 0-2 points. Patients with ECOG 3 may be included if, in the investigator's judgment, removal of the effusion could improve the score to 2 or above.
- •Life expectancy ≥3 months.
- •Adequate major organ function.
- •Able to tolerate thoracentesis/abdominocentesis and catheter placement, or already have a functional thoracic/abdominal drainage catheter in place, and agree to receive study drug treatment via this route.
排除标准
- •Participation in any other interventional clinical trial within 4 weeks prior to the first dose of study drug.
- •Received local intracavitary therapy for pleural/peritoneal effusion (excluding diagnostic or symptom-relieving puncture/drainage) within 2 weeks prior to the first dose of study drug.
- •Received extra-thoracic/extra-abdominal radiotherapy within 2 weeks prior to the first dose of study drug, or received radical radiotherapy to pleural/peritoneal or pulmonary/abdominal lesions within 8 weeks prior to enrollment (palliative radiotherapy to chest/abdomen is permitted).
- •Underwent major thoracic or abdominal surgery within 4 weeks prior to the first dose of study drug and not fully recovered, or planned to undergo elective major surgery during the study period.
- •Any toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 at the start of study treatment.
- •Symptomatic, uncontrolled central nervous system (CNS) metastases or leptomeningeal metastases that, in the investigator's judgment, make the patient unsuitable for enrollment.
- •Known human immunodeficiency virus (HIV) infection, active hepatitis B, active hepatitis C, or active syphilis infection.
- •Active, uncontrolled infection requiring systemic antibiotics, antivirals, or antifungal therapy.
- •Pregnant or breastfeeding women.
- •Definite history of severe mental or cognitive disorders that, in the investigator's opinion, may affect study compliance or safety assessment.
- •Presence of any active autoimmune disease, or history of autoimmune disease requiring systemic immunosuppressive therapy (topical glucocorticoids or inhaled/intra-articular steroids are permitted).
- •Require systemic corticosteroids or other immunosuppressants within 2 weeks prior to the first dose of study drug, and expected to require long-term use during the study.
- •Have poorly controlled or severe cardiovascular disease.
- •Have poorly controlled metabolic disease or complete/severe gastrointestinal obstruction requiring intervention.
- •Hypersensitivity to the investigational drug, any of its excipients, liposomal formulations, or kanamycin.
- •Have had a major thromboembolic event within 6 months prior to the first dose, or have a clear bleeding tendency.
- •Active local infection at the administration site.
- •Uncorrectable coagulation dysfunction that would pose a high risk for thoracentesis/abdominocentesis or catheter placement.
- •Have any other concurrent, serious, and/or uncontrolled medical condition.
研究者
研究点 (1)
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