A Study of JSKN027 in Patients With Advanced Solid Tumors

Inclusion Criteria

• •Age ≥ 18 years at the time of signing the ICF.
• •ECOG performance status 0-1.
• •Estimated life expectancy ≥ 3 months.
• •Histologically or cytologically confirmed advanced or metastatic malignant solid tumor.
• •For dose escalation (Part Ia): disease has progressed on standard therapy.
• •For dose expansion (Part Ib): participants with prespecified tumor types (e.g., colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and other selected solid tumors) who have progressed on standard therapy.
• •At least one measurable extracranial lesion per RECIST v1.1.
• •Adequate bone marrow function within 7 days prior to enrollment (e.g., ANC ≥ 1.5×10\^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100×10\^9/L).
• •Adequate hepatic function within 7 days prior to enrollment (e.g., total bilirubin, AST/ALT, ALP within protocol-defined limits; albumin ≥ 30 g/L).
• •Adequate renal function within 7 days prior to enrollment (e.g., serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min; urine protein within acceptable limits).
• •Adequate coagulation function within 7 days prior to enrollment (e.g., PT/INR and aPTT within protocol-defined limits).
• •Adequate cardiac function (e.g., LVEF ≥ 50%).
• •Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
• •Participants of reproductive potential agree to use highly effective contraception from ICF signing until 7 months after the last dose.