WSK-IM02 in Advanced Solid Tumors With Malignant Effusions (Phase I)

Exclusion Criteria

• •1. Participation in any other interventional clinical trial within 4 weeks prior to the first dose of study drug.
• •2. 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.
• •3. 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).
• •4. 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.
• •5. Any toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 at the start of study treatment.
• •6. Symptomatic, uncontrolled central nervous system (CNS) metastases or leptomeningeal metastases that, in the investigator's judgment, make the patient unsuitable for enrollment.
• •7. Known human immunodeficiency virus (HIV) infection, active hepatitis B, active hepatitis C, or active syphilis infection.
• •8. Active, uncontrolled infection requiring systemic antibiotics, antivirals, or antifungal therapy.
• •9. Pregnant or breastfeeding women.
• •10. Definite history of severe mental or cognitive disorders that, in the investigator's opinion, may affect study compliance or safety assessment.
• •11. Presence of any active autoimmune disease, or history of autoimmune disease requiring systemic immunosuppressive therapy (topical glucocorticoids or inhaled/intra-articular steroids are permitted).
• •12. 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.
• •13. Have poorly controlled or severe cardiovascular disease.
• •14. Have poorly controlled metabolic disease or complete/severe gastrointestinal obstruction requiring intervention.
• •15. Hypersensitivity to the investigational drug, any of its excipients, liposomal formulations, or kanamycin.
• •16. Have had a major thromboembolic event within 6 months prior to the first dose, or have a clear bleeding tendency.
• •17. Active local infection at the administration site.
• •18. Uncorrectable coagulation dysfunction that would pose a high risk for thoracentesis/abdominocentesis or catheter placement.
• •19. Have any other concurrent, serious, and/or uncontrolled medical condition.