A Phase I Study of JSKN021 in Advanced Solid Tumors

Inclusion criteria

• Voluntarily participate and sign the informed consent form.
• Age ≥ 18 and ≤ 75 years old, male or female.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
• Expected survival ≥ 3 months.
• Histologically or cytologically confirmed malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.
• At least one measurable lesion at baseline according to RECIST 1.1 criteria.
• Adequate organ function.
• Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
• Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
• Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
• Adequate washout period of previous therapy before the first dose.

Exclusion criteria

• Complicated with other malignant tumors within 3 years before the first dose.
• History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
• Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.
• Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
• Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
• Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
• Uncontrolled infection.
• Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
• Toxicity of previous anti-tumor treatment has not fully or partially recovered.
• Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
• Pregnant and/or lactating women, or planning to become pregnant during the study period.
• 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.