Clinical trial · Interventional
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
NCT06855069CI-TRIAL-00099156recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| HS-20089 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group 1: HS-20089
- interventionNames
- Drug: HS-20089
- type
- ACTIVE_COMPARATOR
- label
- Treatment group 2: Investigator's choice of chemotherapy
- interventionNames
- Drug: Paclitaxel
- Drug: Doxorubicin
- Drug: Topotecan
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1
- timeFrame
- Screening up to study completion, an average of 1 year
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.