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;
Parallel
HLX43
DrugHLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
ORR
Objective response rate (ORR) (assessed by INV according to the RECIST v1.1 criteria)
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV according to the RECIST v1.1 criteria.
ORR
Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC according to the RECIST v1.1 criteria.
OS
Overall Survival
Incidence and severity of adverse events (AEs)
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version \[v\] 5.0
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