Patients with advanced solid tumors confirmed by histopathology or cytology (including but not limited to lung cancer, gastric cancer, ovarian cancer, breast cancer, pancreatic cancer, etc.).
Conditions
Interventions
Experimental:A traditional "3+3" design was adopted for dose escalation. The starting dose was 3.33 µg/kg, with subsequent escalating doses of 8.33 and 16.67 µg/kg. The study drug was administered via
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and =3 months. 8. Adequate major organ function, meeting the following criteria from laboratory tests within 14 days prior to treatment:; 9. Hematology (no blood transfusion or hematopoietic growth factor support within 14 days): Absolute neutrophil count (NEUT) >=1.5×10?/L; Platelet count (PLT) >=80×10?/L; Hemoglobin (Hb) >=80 g/L. 10. Liver function: Alanine aminotransferase (ALT) 50 mL/min. 12. Coagulation function: Activated partial thromboplastin time (APTT) <=1.5 × ULN; International normalized ratio (INR) <=1.5 × ULN. 13. Subjects of childbearing potential (both male and female) must agree to use highly effective contraceptive measures from the time of signing informed consent until at least 6 months after the last dose of the study drug. 14. Able to tolerate thoracentesis/paracentesis catheter placement or already have a functional thoracic/abdominal drainage catheter, and agree to receive study drug administration via this route.
Exclusion criteria
Exclusion criteria: 1. Participation in any other drug clinical trial within 4 weeks prior to the first administration of the study drug; 2. Receipt of local intracavitary therapy (e.g., talc, bleomycin, anti-angiogenic agents, etc.) for pleural/ascitic fluid within 2 weeks prior to the first administration of the study drug, excluding simple diagnostic or symptom-relieving paracentesis/drainage; 3. Extra-thoracic/extra-abdominal radiotherapy within 2 weeks prior to the first administration of the study drug, or radical radiotherapy to the pleura/peritoneum or pulmonary/abdominal lesions within 8 weeks prior to enrollment (Note: Palliative radiotherapy to the chest/abdomen is permitted); 4. Major thoracic or abdominal surgery within 4 weeks prior to the first administration of the study drug without full recovery, or planned elective major surgery during the study period; 5. Any toxicity from prior anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, or immunotherapy) that has not resolved to = Grade 1 (according to NCI-CTCAE v6.0) at the start of study treatment, except for toxicities such as alopecia, pigmentation, or other toxicities deemed by the investigator to pose no safety risk; 6. Symptomatic, uncontrolled central nervous system (CNS) metastases or leptomeningeal metastases that are deemed unsuitable for enrollment by the investigator; 7. Known human immunodeficiency virus (HIV) infection, active hepatitis B (HBsAg positive with HBV DNA > 500 IU/mL or above the upper limit of normal of the study center; patients whose HBV DNA returns to normal range after effective antiviral therapy may be enrolled), active hepatitis C (HCV antibody positive with HCV RNA positive), or active syphilis infection; 8. Active, uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals (as judged by the investigator); 9. Pregnant or lactating women; 10. Known history of drug abuse, alcohol abuse, or substance abuse; prior definite history of severe mental or cognitive impairment that may affect study compliance or safety assessment as judged by the investigator; 11. Presence of any active autoimmune disease, or history of autoimmune disease requiring systemic immunosuppressive therapy (e.g., corticosteroids >10 mg/day prednisone equivalent, methotrexate, mycophenolate mofetil, etc.); topical corticosteroids or inhaled/intra-articular steroids are permitted; 12. Need for systemic corticosteroids (at a dose equivalent to prednisone >10 mg/day) or other immunosuppressants within 2 weeks prior to the first administration of the study drug, with anticipated long-term use during the study period; 13. Poorly controlled or severe cardiovascular disease, such as: New York Heart Association (NYHA) class II-IV heart failure; unstable angina or myocardial infarction within 6 months prior to first dose; clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention; poorly controlled blood pressure despite antihypertensive therapy (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg); 14. Poorly controlled metabolic disease (e.g., diabetes with HbA1c >=8% with clinical symptoms), prior history of severe gastrointestinal bleeding, current uncontrolled severe diarrhea (CTCAE Grade >=2), or complete/severe gastrointestinal obstruction requiring intervention; 15. Known hypersensitivity to the study drug (WSK-IM02) or any of its excipients, liposomal formulations, or kanamycin;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactHuashan Shi
West China Hospital of Sichuan University
Outcome results
None listed