drugset / Trial / NCT06990516
SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer
NaSingle-groupOpen-labelTreatment
Summary
This study is a multi - center, single - arm, open - label, phase Ib/II clinical trial for dose exploration and efficacy expansion. The aim is to evaluate the tolerability, safety, pharmacokinetic characteristics, and immunogenicity of the combination regimen of SHR - A1811 in the treatment of platinum - sensitive recurrent epithelial ovarian cancer, determine the recommended phase II dose (RP2D) of the combination therapy, and preliminarily assess its efficacy.
Timeline
- Start
- 2025-06-01
- Primary completion
- 2030-06-01
- Completion
- 2035-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 3.2 mg/kg | Intravenous |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Trastuzumab Rezetecan | Monoclonal antibody | 4.8 mg/kg | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |