drugset / Trial / NCT05831891
Fruquintinib Plus Serplulimab as First-Line Therapy for Metastatic Non-Clear Cell Renal Cell Carcinoma
Phase 2
Active not recruiting
39 enrolled
RenJi Hospital
Peking University Third Hospital · collabShanghai Zhongshan Hospital · collabSun Yat-Sen University Cancer Center · collab
NaSingle-groupOpen-labelTreatment
Summary
This multicenter, single-arm, phase II study (FRONTIER) evaluates the efficacy and safety of fruquintinib combined with serplulimab as first-line treatment in patients with metastatic or unresectable non-clear cell renal cell carcinoma (nccRCC). Given the biological heterogeneity and lack of established standard therapies in nccRCC, this study aims to characterize clinical outcomes and explore potential predictive biomarkers associated with treatment benefit.
Timeline
- Start
- 2023-05-01
- Primary completion
- 2026-07-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fruquintinib | Small molecule | 5 mg | Oral |
| Subject | Serplulimab | Monoclonal antibody | 4.5 mg/kg | Intravenous |