drugset / Trial / NCT03763123
A Phase 1b Study of Sevacizumab in Combination With Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent Ovarian Cancer.
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with Chemotherapy in Chinese patients with Platinum-Resistant Recurrent Ovarian Cancer. This study includes two stages. Stage 1 is the dose-escalation stage. Once the maximum tolerated dose (MTD of Sevacizumab has been established, additional patients will be enrolled in the cohort-expansion stage (Stage 2).
Timeline
- Start
- 2018-04-24
- Primary completion
- 2019-12-31
- Completion
- 2020-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Suvemcitug | Monoclonal antibody | 0.5 mg/kg | — |
| Subject | Suvemcitug | Monoclonal antibody | 1 mg/kg | — |
| Subject | Suvemcitug | Monoclonal antibody | 1.5 mg/kg | — |
| Subject | Suvemcitug | Monoclonal antibody | 2 mg/kg | — |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Background | Topotecan | Small molecule | 4 mg/m2 | Intravenous |