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Clinical Trials in China / NCT06855069
Recruiting Phase 3

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

NCT06855069 · tracked via the Priya Life Science China tracker
Sponsor
Hansoh BioMedical R&D Company
Phase
Phase 3
Started
2025-03-13
Last updated
2025-12-17

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

HS-20089 →Paclitaxel →Doxorubicin →Topotecan →

HS-20089: HS-20089 dose 1

Paclitaxel: Paclitaxel dose 2

Doxorubicin: Doxorubicin dose 3

Topotecan: Topotecan dose 4

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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 requiring clinical intervention. 4. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment. 5. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy. 6. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of HS-20089. 7. 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. 8. Other inappropriate situation considered by the investigator.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cancer Hospital, Chinese Academy of Medical Sciences Beijing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06855069 on ClinicalTrials.gov ↗ ← All trials in China