A Clinical Study of SHR-4506 Injection in Patients With Malignant Tumors

Inclusion criteria

• Age ≥18 years, any gender.
• ECOG performance status 0-1.
• Histologically or cytologically confirmed malignant tumor patients who have failed standard therapy, or are intolerant to standard therapy, or have no standard treatment available.
• Adequate organ function.
• Voluntary participation in this clinical trial, with full understanding of study procedures and ability to provide written informed consent.
• Expected survival ≥12 weeks.
• Patients in the dose-expansion phase must have measurable lesions.
• Agreement to use contraception from the time of signing the informed consent to at least 60 days after the last dose of the investigational drug.

Exclusion criteria

• Prior treatment with the same class of investigational drug.
• Confirmed or suspected central nervous system (CNS) tumor involvement.
• Uncontrolled tumor-related pain.
• Active autoimmune disease, history of immunodeficiency (including primary or secondary, e.g., HIV infection), or autoimmune disorders requiring systemic therapy.
• Clinically significant cardiovascular disease history.
• Known hypersensitivity to any component of the investigational drug.
• Major surgery or significant trauma within 4 weeks prior to the first dose of the investigational drug; diagnostic or superficial surgery within 7 days before the first dose; or planned major surgery during the study period.
• Adverse events from prior therapy have not recovered to ≤ CTCAE Grade 1.
• Severe infection within 4 weeks before the first dose, or active infection within 2 weeks.
• History of cerebrovascular accident within 6 months before the first dose of the investigational drug.
• Patients with other active malignancies within 2 years prior to the first dose or concurrent malignancies.
• Patients with any other condition judged by the investigator that makes the patient unsuitable for participation in the study.