HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
NCT ID: NCT06855069
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
468 participants
INTERVENTIONAL
2025-03-13
2029-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group 1: HS-20089
HS-20089
HS-20089 dose 1
Treatment group 2: Investigator's choice of chemotherapy
Paclitaxel
Paclitaxel dose 2
Doxorubicin
Doxorubicin dose 3
Topotecan
Topotecan dose 4
Interventions
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HS-20089
HS-20089 dose 1
Paclitaxel
Paclitaxel dose 2
Doxorubicin
Doxorubicin dose 3
Topotecan
Topotecan dose 4
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Hansoh BioMedical R&D Company
INDUSTRY
Responsible Party
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Principal Investigators
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Lingying Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Other Identifiers
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HS-20089-301
Identifier Type: -
Identifier Source: org_study_id