JSKN022 in Subjects With Advanced Malignant Solid Tumors

Exclusion Criteria

• •1. Complicated with other malignant tumors within 5 years before the first dose, except for tumor types that have achieved clinical cure through local treatment with extremely low recurrence risk or tumor types with disease-free survival ≥ 5 years after radical treatment and extremely low recurrence/metastasis risk.
• •2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
• •3. Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula, except those judged by the investigator and medical monitor to not affect the patient's enrollment and administration.
• •4. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
• •5. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
• •6. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
• •7. Gastrointestinal abnormalities with obvious clinical manifestations.
• •8. Active autoimmune diseases requiring systemic treatment within the past two years.
• •9. Significant serous effusion.
• •10. Uncontrolled infection.
• •11. Require regular glucocorticoid or immunosuppressive therapy.
• •12. Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
• •13. Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors.
• •14. Previous occurrence of grade ≥ 3 immune-related adverse events during immunotherapy.
• •15. Toxicity of previous anti-tumor treatment has not fully or partially recovered.
• •16. Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
• •17. Pregnant and/or lactating women, or planning to become pregnant during the study period.
• •18. Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.
• •19. Local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to high medical risks and/or uncertainty in survival assessment, such as tumor-related leukemia reaction (white blood cell count \> 20×10⁹/L), cachexia manifestations, etc.
• •20. Any other previous or current diseases, treatments, or laboratory test abnormalities that the investigator deems may confuse the study results, affect the patient's full participation in the study, or participation in the study may not be in the best interest of the patient.