SHR - A1811 Versus Chemotherapy for Platinum-resistant Recurrent Epithelial Ovarian Cancer
Summary
This study is a randomized, open-label, active-controlled, multicenter phase III clinical trial. It is planned to enroll 300 subjects with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with HER2 expression. The randomization will be stratified according to the following factors: 1) HER2 immunohistochemistry (IHC) expression status (HER2 IHC 1+ versus HER2 IHC 2+/3+); 2) whether the subject has previously received vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) inhibitors such as bevacizumab (yes versus no). Subjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (SHR - A1811) or the control treatment group (chemotherapy chosen by the investigator, namely liposomal doxorubicin, paclitaxel, topotecan, or gemcitabine).
Timeline
- Start
- 2025-06-01
- Primary completion
- 2030-06-01
- Completion
- 2035-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Doxorubicin | Other / unclassified | 40 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Comparator | Topotecan | Small molecule | 4 mg/m2 | Intravenous |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 4.8 mg/kg | Intravenous |