NCT05078593

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection in Patients With Solid Tumor or Lymphoma

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection (Anti LAG-3 Monoclonal Antibody) in Patients With Advanced/Metastatic Solid Tumor or Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a first-in-class open-label phase I human clinical study to evaluate the safety and tolerability of HLX26 with escalated doses in the treatment of patients with advanced/metastatic solid tumors or lymphomas.

Detailed description

This study is a first-in-class open-label phase I human clinical study to evaluate the safety and tolerability of HLX26 with escalated doses in the treatment of patients with advanced/metastatic solid tumors or lymphomas. In this study, accelerated titration is combined with a 3 + 3 dose escalation method, and the patients will be given different doses(60mg, 150mg, 300mg, 500mg, 800mg Q3W) of HLX26 intravenously. Observation period of DLT lasts for 3 weeks after the first administration of HLX26.

Conditions

• Solid Tumor, Adult
• Lymphoma

Interventions

Type	Name	Description
DRUG	HLX26	Humanized Anti-Lymphocyte Activation Gene-3 Monoclonal Antibody

Timeline

• Start date: 2021-10-11
• Primary completion: 2023-08-18
• Completion: 2023-08-18
• First posted: 2021-10-14
• Last updated: 2024-02-23

Locations

1 site across 1 country: China