drugset / Trial / NCT04716634

Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors

NCT04716634

Phase 2 Completed 84 enrolled BeiGene Hutchison Medipharma Limited · collab
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

EvaluationDrugModalityDoseRoute
Subject Fruquintinib Small molecule 5 mg Oral
Subject Tislelizumab Monoclonal antibody 300 mg Intravenous

Indications