JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

A Randomized, Open-Label, Parallel-Controlled, Multi-center Phase Ⅲ Study of JSKN003 Versus Investigator-Choice Chemotherapy for Platinum-Resistant, Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube cancer.

Inclusion Criteria:

• Voluntary participation and written informed consent.
• ≥18 years;
• Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• Confirmed platinum-resistant relapse.
• According to RECIST 1.1 criteria, there must be at least one measurable lesion in the baseline.
• Expected survival of more than 3 months.
• ECOG performance status score of 0 or 1.
• Adequate organ function.
• Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.

Exclusion Criteria:

• Primary platinum-refractory disease.
• Active central nervous system metastases.
• Uncontrolled pleural effusion.
• Previous treatment with topoisomerase I inhibitor ADCs.
• Other malignant tumors within 5 years.
• Interstitial pneumonia/lung disease requiring systemic corticosteroids or suspected interstitial pneumonia/lung disease.
• Uncontrolled comorbidities.
• Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1.
• History of allogeneic bone marrow or organ transplantation.
• Allergic reactions or hypersensitivity to antibody drugs.
• Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.