drugset / Trial / NCT05641493

A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of HLX208+HLX10 in NSCLC With BRAF V600E Mutation

NCT05641493

Phase 1/2 Unknown 49 enrolled Shanghai Henlius Biotech
NaSingle-groupOpen-labelTreatment

Summary

An open-label, multicenter phase Ib/II clinical study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HLX208 (BRAF V600E Inhibitor) combined with HLX10 (anti-PD-1 monoclonal antibody)in advanced NSCLC patients with BRAF V600 mutation.

Timeline

Start
2023-02-28
Primary completion
2025-03-04
Completion
2026-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX208 Unknown 600 mg Oral
Subject HLX208 Unknown 900 mg Oral
Subject Serplulimab Monoclonal antibody 300 mg Intravenous