Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor

Phase 1 Completed 9 enrolled Shanghai Henlius Biotech

Non-randomizedSequentialOpen-labelTreatment

Summary

This study is a open-label, phase I, dose escalation clinical study to evaluate the safety and tolerability of HLX26 and HLX10 in the treatment of patients with advanced/metastatic solid tumors.

Timeline

Start: 2022-07-26
Primary completion: 2023-08-31
Completion: 2024-01-31

Publications

Liu R, Jing H, Chen Y, Gao S, Zhang J, Cao X, Li K, Liu Y, Meng M, Chen C, Sun C, Yu H, Wang Q, Li J, Wu Y, Zhang J. Phase I Studies of HLX26, A Novel Anti-LAG-3 Antibody, Monotherapy or Combination Therapy in Patients with Advanced Solid Tumors. BioDrugs. 2026 Mar;40(2):335-348. doi: 10.1007/s40259-025-00751-z. Epub 2026 Jan 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HLX26	Monoclonal antibody	500 mg	Intravenous
Subject	HLX26	Monoclonal antibody	800 mg	Intravenous
Subject	HLX26	Monoclonal antibody	1600 mg	Intravenous
Subject	Serplulimab	Monoclonal antibody	300 mg	Intravenous

Indications

No indication recorded.