Clinical trial · Interventional
A Study of SHR-A1811 in Subjects With Ovarian Cancer
An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT06828354CI-TRIAL-00108848recruitingPhase 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 is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin Hydrochloride Liposome Injection | Drug | Doxorubicin | ALIAS |
| Gemcitabine Hydrochloride for Injection | Drug | Gemcitabine | ALIAS |
| Paclitaxel Injection | Drug | Paclitaxel | ALIAS |
| SHR-A1811 | Drug | — | UNRESOLVED |
| Topotecan Hydrochloride for Injection | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-A1811 group
- interventionNames
- Drug: SHR-A1811
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy group
- interventionNames
- Drug: Paclitaxel Injection
- Drug: Doxorubicin Hydrochloride Liposome Injection
- Drug: Gemcitabine Hydrochloride for Injection
- Drug: Topotecan Hydrochloride for Injection
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- From day 1 to 10 months.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subjects voluntarily joined the study and signed the Informed consent forms (ICF). 2. Measurable disease, as defined by RECIST v1.1. 3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 12 weeks. Exclusion Criteria: 1. Symptomatic, untreated or active central nervous system metastases. 2. Have uncontrolled or severe cardiovascular disease. 3. With any active autoimmune disease or history of autoimmune disease. 4. Patients with active hepatitis B or hepatitis C. 5. Severe infections prior to initiation of study treatment. 6. Patients with active tuberculosis.
References
Publications (0)
Data not yet available
No reference posted for this study.