Clinical trial · Interventional
SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
NCT06394492CI-TRIAL-00079664recruitingPhase 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 SHR-A1921 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 |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| SHR-A1921 | Drug | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group 1: SHR-A1921
- interventionNames
- Drug: SHR-A1921
- type
- ACTIVE_COMPARATOR
- label
- Treatment group 2: Investigator's choice of chemotherapy
- interventionNames
- Drug: Doxorubicin
- Drug: Paclitaxel
- 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 (7)
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 tumour 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. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms. 2. Previous or co-existing malignancies. 3. Current or History of ILD. 4. Clinical symptoms or diseases of the heart that are not well controlled. 5. Arterial/venous thrombosis events occurred before the first dose. 6. Grade ≥2 bleeding events of CTCAE occurred before the first dose. 7. Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose. 8. Patients with intestinal obstruction or parenteral nutrition before the first dose. 9. Serious infection before the first dose. 10. Active hepatitis B or active hepatitis C. 11. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment. 12. Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload. 13. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy. 14. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921. 15. Other inappropriate situation considered by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.