JSKN033 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN033 versus investigator's choice of chemotherapy in patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy and PD-1/L1 inhibitor therapy.

Inclusion Criteria: * Voluntary participation and written informed consent. * ≥18 years; * ECOG performance status score of 0 or 1. * Expected survival of more than 3 months. * Histologically or cytologically confirmed recurrent or metastatic cervical cancer. * At least one measurable lesion in the baseline. * Adequate organ function. * Provide primary or metastatic tumor samples. * Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures. Exclusion Criteria: * Tumors with histologic components other than squamous-cell carcinoma and adenocarcinoma. * Other-malignancy diagnosed within 3 years prior to randomization. * Active central nervous system metastases. * Baseline imaging showing tumor invasion, compression of, or arising from vital organs. * Prior treatment with topoisomerase I inhibitors or topoisomerase I inhibitor based antibody-drug conjugates. * Inadequate washout from prior therapy before randomization. * Risk factors for ILD. * Significant cardiovascular or cerebrovascular disease. * Clinically-significant gastrointestinal abnormalities. * History of genital-tract fistula. * Uncontrolled pleural effusion. * Active or prior autoimmune-disease . * Uncontrolled infection. * Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1. * History of ≥Grade 3 immune-related adverse events irAEs. * Previous allogeneic bone-marrow or solid organ transplantation. * Allergic reactions or hypersensitivity to any component of JSKN033 or the assigned chemotherapy agent. * Pregnant or lactating female participants, or women planning pregnancy during the study. * Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.