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

Prior treatment

• Other-malignancy diagnosed within 3 years prior to randomization.
• Prior treatment with topoisomerase I inhibitors or topoisomerase I inhibitor based antibody-drug conjugates.
• Inadequate washout from prior therapy before randomization.
• Active or prior autoimmune-disease .
• Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1.
• Previous allogeneic bone-marrow or solid organ transplantation.

Other illness

• Significant cardiovascular or cerebrovascular disease.
• History of genital-tract fistula.
• Uncontrolled infection.
• History of ≥Grade 3 immune-related adverse events irAEs.
• Allergic reactions or hypersensitivity to any component of JSKN033 or the assigned chemotherapy agent.
• Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.

Other

• Tumors with histologic components other than squamous-cell carcinoma and adenocarcinoma.
• Active central nervous system metastases.
• Baseline imaging showing tumor invasion, compression of, or arising from vital organs.
• Risk factors for ILD.
• Clinically-significant gastrointestinal abnormalities.
• Uncontrolled pleural effusion.
• Pregnant or lactating female participants, or women planning pregnancy during the study.

• 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.