The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic cervical cancer or ovarian cancer failed or intolerance to standard first-line therapy.
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.
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;
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China