HS-20089 injection for 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
This trial will test whether HS-20089 works better than the doctor's choice of chemotherapy for adults with platinum-resistant recurrent epithelial ovarian cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 468 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hansoh BioMedical R&D Company Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06855069 on ClinicalTrials.gov |
What this trial studies
This randomized, open-label phase III trial compares HS-20089 injections to investigator-selected chemotherapy (paclitaxel, doxorubicin, or topotecan) in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Eligible adult women must have pathologically confirmed disease, measurable lesions by RECIST v1.1, ECOG 0–1, adequate organ function, and be able to provide fresh or archived tumor tissue. Patients are excluded if they received prior TOP1 inhibitors or TOP1-payload ADCs, have recent systemic anticancer therapy within 4 weeks, unresolved grade ≥2 toxicities, or uncontrolled effusions requiring intervention. The trial will monitor efficacy and safety endpoints to determine whether HS-20089 offers improved outcomes over standard chemotherapy choices.
Who should consider this trial
Good fit: Ideal candidates are adult women with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have measurable disease, ECOG 0–1, sufficient organ function, and can provide tumor tissue.
Not a fit: Patients previously treated with TOP1 inhibitors or TOP1-payload ADCs, those with uncontrolled effusions, recent systemic therapy, unresolved significant toxicities, or poor performance status are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, HS-20089 could provide a new effective treatment option that prolongs disease control for patients with platinum-resistant ovarian cancer.
How similar studies have performed: Related TOP1-targeting ADCs have shown activity in early trials for solid tumors, but randomized phase III evidence in platinum-resistant ovarian cancer remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Lingying Wu, MD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study coordinator: Lingying Wu, MD
- Email: wulingying@csco.org.cn
- Phone: (+86)13910865483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.