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

Inclusion criteria

• ✓. Volunteer to participate in clinical research; To fully understand and understand this study and to sign the Informed Consent Form (ICF); Willing to follow and able to complete all test procedures;
• ✓. The age of signing ICF is ≥ 18 years old and ≤ 75 years old;
• ✓. Cohort 1: Metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology confirmed by histopathology or cytology.
• ✓. Cohort 1: Previous failure or progression of standard systemic therapy for cervical cancer (For patients with PD-L1 expression positive \[CPS≥1\], the standard therapy is defined as platinum-based chemotherapy in combination with immune checkpoint inhibitor (ICI) therapy; for patients with PD-L1 expression negative \[CPS\<1\], the standard therapy is defined as platinum-based chemotherapy), or intolerability toxicity (CTCAE≥3 adverse events), or contraindications to standard therapy.
• ✓. Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST v1.1 criteria;
• ✓. Tumor tissue should be provided as much as possible for an evaluable PD-L1 expression result at Screening period；
• ✓. Before the initial administration of the study drug, there should be at least a 3-week interval or 5 times the half-life of the last cytotoxic chemotherapy, immunotherapy, or biological therapy, whichever is shorter. There should be at least a 2-week interval from the previous small molecule targeted therapy, at least a 1-week interval from traditional Chinese medicine treatment with antitumor indications or minor surgery. Additionally, treatment-related adverse events (AEs) should have recovered to NCI-CTCAE grade ≤ 1 (except for grade 2 peripheral neurotoxicity and alopecia)；
• ✓. The ECOG physical performance score of 0-1 in the week prior to randomization；