HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Ca
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of HS-20089 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
| Condition(s) | Ovarian Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of HS-20089 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer. |
| Who can participate | Inclusion Criteria: 1. Voluntary participation and written informed consent. 2. 18 years and older, female. 3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. 4. Patients must have platinum-resistant disease 5. Be able to provide fresh or archived tumor tissue. 6. At least one measurable lesion according to RECIST v1.1. 7. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 8. With a life expectancy \> 12 weeks. 9. Adequate bone marrow reserve and organ function. 10. Contraception is required during the trial. Exclusion Criteria: 1. Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload. 2. Previous or co-existing malignancies. 3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiri |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Hansoh BioMedical R&D Company |
| Locations | Beijing, China |
| Start date | 2025-03-13 |
| NCT ID | NCT06855069 |
| Official listing | https://clinicaltrials.gov/study/NCT06855069 |