A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors

Exclusion criteria

• . History of any second malignant tumor within the first 2 years prior to randomization;
• . Subjects who are preparing for or have previously received an organ or bone marrow transplant;
• . Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases;
• . After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently;
• . Present with grade ≥1 radiation pneumonia as defined by RTOG/EORTC; A history of interstitial lung disease (ILD) or imaging findings during screening that suggest such disease is suspected; Or there are lung diseases leading to clinical severe respiratory impairment;
• . Subjects exhibit poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure, or left ventricular ejection fraction (LVEF) \< 50%; (2) unstable angina; (3) myocardial infarction or cerebrovascular accident within the last 6 months (excluding lacunar infarction, minor ischemic stroke, or transient ischemic attack); (4) uncontrolled arrhythmias (including QTc interval ≥ 450 ms for males, ≥ 470 ms for females) (QTc interval calculated by Fridericia's formula); (5) poorly controlled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg despite active treatment);
• . Previous occurrence of adverse events leading to permanent discontinuation of immunotherapy; or A history of ≥ Grade 2 immune-related pneumonia or myocarditis;
• . Active or suspected autoimmune disease. Patients with autoimmune-related hypothyroidism who are undergoing thyroid hormone replacement therapy are permitted to participate in the study; patients with controlled Type 1 diabetes mellitus receiving insulin therapy are also allowed to participate in the study;