HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
A Multi-center, Randomized, Open-label, Controlled, Phase III Clinical Study Evaluating HS-20089 vs. Investigator's Choice of Chemotherapy in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Hansoh BioMedical R&D Company
468 participants
Mar 13, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria8
- 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.
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Interventions
HS-20089 dose 1
Paclitaxel dose 2
Doxorubicin dose 3
Topotecan dose 4
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06855069