JSKN033 in Chinese Subjects with Advanced Malignant Tumors

Inclusion criteria

• Be able to understand informed consent form, voluntarily participate and sign informed consent form.
• Age ≥18 year (at the time consent is obtained), male or female.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Has a Life expectancy ≥3 months.
• Has a pathologically documented advanced/unresectable or metastatic solid malignant tumor that is refractory to or intolerable with standard treatment.
• Has at least 1 measurable lesion at baseline according to RECIST 1.1 criteria.
• Must have adequate organ function prior to the start of JSKN033.
• Negative urine/serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.

Exclusion criteria

• Has clinically active brain metastases.
• Previously received any other investigational drug within 28 days prior to enrollment.
• Previously received local palliative treatment within 14 days prior to enrollment.
• Previously received major surgeries within 28 days prior to enrollment.
• Need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment.
• Previously received live vaccine within 28 days prior to enrollment.
• Previously received antibody conjugate drug with topoisomerase I inhibitor.
• Has a history of other primary malignant tumors within 5 years prior to enrollment.
• Has uncontrolled comorbidities as specified by the protocol.
• Has a history of interstitial pneumonia/lung disease requiring systemic hormonal therapy, or suspected interstitial pneumonia/lung disease that cannot be ruled out by imaging during screening period.
• Subjects with uncontrolled large serous cavity effusion or moderate to large serous cavity effusion requiring repeated drainage (recurrent within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, etc.
• Toxicities of previous antitumor therapy did not resolve to grade 1 defined by CTCAE v5.0.
• Has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient to the study drug.
• Has a history of allogeneic bone marrow or organ transplantation.
• Pregnant or breastfeeding female patients.
• Other conditions that the investigator considers unsuitable to participate in this clinical trial, including but not limited to psychiatric disorders, alcoholism or drug abuse, etc.