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.

Exclusion Criteria:

* Active central nervous system (CNS) disease (e.g., active brain metastases or leptomeningeal disease).
* Received an investigational agent within 28 days or 5 half-lives (whichever is shorter) prior to first dose.
* Major surgery within 28 days prior to first dose or planned major surgery during the study.
* History of severe immune-related adverse events or prior toxicity that would preclude safe participation, as judged by the investigator.
* Significant gastrointestinal disorders that increase risk of perforation, bleeding, obstruction, or interfere with study participation.
* Active or uncontrolled interstitial lung disease (ILD) or non-infectious pneumonitis, or suspected ILD/pneumonitis at screening.
* Active autoimmune disease requiring systemic immunosuppression (exceptions may apply for limited, stable conditions).
* Active hepatitis B or C, HIV infection, or other clinically significant immunodeficiency/infection not adequately controlled per local standards.
* Prior allogeneic organ or bone marrow transplant.
* Known hypersensitivity to the study drug or its excipients, or history of severe hypersensitivity to similar biologic agents.
* Pregnant or breastfeeding.
* Any condition that, in the investigator's judgment, would compromise participant safety or compliance.