A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors

This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor.

Inclusion criteria

• Subjects aged 18-75 years at the time of signing the informed consent form
• Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors .
• Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
• Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.
• Subjects who are assessed by the investigator to have an expected survival of ≥ 3 months.
• Subjects who have adequate organ function.
• Subjects who have recovered from all toxicities due to prior therapy .
• Male and female subjects must agree to use highly effective contraception methods during the study treatment.
• Subjects who voluntarily sign the informed consent form.

Exclusion criteria

• Subjects with known active or untreated central nervous system (CNS) metastases.
• Subjects with other malignant tumors within 3 years prior to the first dose.
• Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
• Subjects with known active pulmonary tuberculosis.
• Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.
• Subjects with major surgery within 28 days prior to the first dose.
• Subjects with known allergy or hypersensitivity to SKB571 or its excipients.
• Subjects with clinically severe lung injuries due to pulmonary complications.
• Subjects with a history of allogeneic tissue/solid organ transplant.
• Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage.
• Subjects who have received live vaccines within 30 days prior to the first dose of study treatment, or who are scheduled to receive live vaccines during the study.
• Subjects who have received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors within 2 weeks prior to the first dose of study treatment or within 5 half-lives of known drug, whichever is longer.
• Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment.
• Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment.
• Subjects with any disease requiring systemic treatment with corticosteroids (prednisone at doses > 10 mg/d or similar drugs with equivalent doses) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment.
• Subjects have received an investigational agent or has used an investigational device within 28 days prior to initial dose administration of SKB571.
• Subjects whose condition deteriorates rapidly before the first dose, such as a severe physical impariment or a change in ECOG score no longer meeting the inclusion criteria.
• Subjects with a known history of psychosis or drug abuse that will preclude the subject from completing the study.
• Any condition that, in the opinion of the investigator, will interfere with the assessment of study treatment or the safety of the subject or the interpretation of the study results.