Phase II Study of HLX43 Anti-PD-L1 ADC for Women With Advanced Recurrent or Metastatic Cervical or Ovarian Cancer After Standard Treatment

What this Trial Is About

Researchers are evaluating HLX43, an anti-PD-L1 antibody linked to a potent DNA topoisomerase I inhibitor, in patients with recurrent or metastatic cervical or ovarian cancer who have not responded to or cannot tolerate standard first-line treatments. This open-label phase II study aims to find the best dose and assess the drugs effectiveness, safety, and tolerability in this group. Participants will be randomly assigned to one of three different HLX43 dosing groups, all given through intravenous infusion every three weeks. The study includes multiple dosing strategies, including a loading dose option, to compare how the drug performs at different levels. Throughout the study, patients will undergo regular assessments including tumor measurements based on RECIST v1.1 criteria, evaluation of PD-L1 expression from tumor tissue, and monitoring of side effects and overall health status. The main outcomes measured are objective response rate up to 24 weeks and progression-free survival assessed up to 14 months. Safety and survival will also be tracked for up to 24 and 36 months, respectively, with the total duration depending on individual treatment response and follow-up.

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