drugset / Trial / NCT04716634
Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This was an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in participants with advanced or metastatic, unresectable gastric cancer (GC), or colorectal cancer (CRC) or non-small cell lung cancer (NSCLC). The study was conducted in 2 parts. Part 1 was the safety run-in stage to determine dose-limiting toxicity (DLT) and recommended Phase 2 dose (RP2D). Part 2 assessed the preliminary efficacy of tislelizumab in combination with fruquintinib in participants as measured by the overall response rate (ORR) and other efficacy and safety profiles.
Timeline
- Start
- 2021-04-19
- Primary completion
- 2024-02-22
- Completion
- 2024-02-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fruquintinib | Small molecule | 5 mg | Oral |
| Subject | Tislelizumab | Monoclonal antibody | 300 mg | Intravenous |