NCT06855069RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 468 (estimated)
- First submitted
- 25 Feb 2025
- Start date
- 13 Mar 2025
- Primary completion date
- 7 Mar 2027
- Lead sponsor
- Hansoh BioMedical R&D Company
- Diseases
- Ovarian cancer
- NCT number
- NCT06855069
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 468
- From 13 Mar 2025 to the primary completion date, 7 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
- Previous or co-existing malignancies.
- Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
- Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
Other illness
- 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
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
- Other inappropriate situation considered by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.