HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

Inclusion criteria

• Voluntary participation and written informed consent.
• 18 years and older, female.
• Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
• Patients must have platinum-resistant disease
• Be able to provide fresh or archived tumor tissue.
• At least one measurable lesion according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) score: 0-1.
• With a life expectancy > 12 weeks.
• Adequate bone marrow reserve and organ function.
• Contraception is required during the trial.

Exclusion criteria

• Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
• Previous or co-existing malignancies.
• Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
• Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
• Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
• History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of HS-20089.
• Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with the study participation or study drug administration.
• Other inappropriate situation considered by the investigator.