drugset / Trial / NCT03976856
Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib
NaSingle-groupOpen-labelTreatment
Summary
This study is a multi-center, open-label, dose-finding phase Ib clinical study with extension phase, which is aimed at evaluating the efficacy and safety of GB226 combined with fruquintinib in treatment of relapsed or metastatic NSCLC patients with EGFR-sensitive mutations who have failed to respond to EGFR-TKI treatment,evaluating the pharmacokinetic characteristics of GB226 and fruquintinib, and the immunogenicity of GB226, and preliminarily evaluating the antitumor activity of GB226 and fruquintinib.
Timeline
- Start
- 2019-07-23
- Primary completion
- 2021-12
- Completion
- 2022-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APL-501 | Monoclonal antibody | 210 mg | Intravenous |
| Subject | Fruquintinib | Small molecule | 3 mg | Oral |
| Subject | Fruquintinib | Small molecule | 4 mg | Oral |
| Subject | Fruquintinib | Small molecule | 5 mg | Oral |