NCT05400265

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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 Monoclonal Antibody Injection in Combination With HLX10 Monoclonal Antibody Injection in Patients With Advanced/Metastatic Solid Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. In this study, a 3 + 3 dose escalation design was used. The patients will be given different doses(500mg, 800mg Q3W) of HLX26 Plus fixed dose of HLX10(300mg) intravenously. Observation period of DLT lasts for 3 weeks after the first administration of HLX26.

Conditions

• Adult Solid Tumor

Interventions

Type	Name	Description
DRUG	HLX26	Humanized Anti-Lymphocyte Activation Gene-3 Monoclonal Antibody
DRUG	HLX10	Humanized Anti-Programmed Death-1 Monoclonal Antibody

Timeline

• Start date: 2022-07-26
• Primary completion: 2023-08-31
• Completion: 2024-01-31
• First posted: 2022-06-01
• Last updated: 2024-02-06

Locations

1 site across 1 country: China