NCT03916094

Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of HLX22 Monoclonal Antibody Injection (HER2 Monoclonal Antibody) in Patients With Advanced Solid Tumours Overexpressing HER2

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX22 in patients with advanced solid tumors overexpressing HER2 after failure of standard of care.

Detailed description

This study is an open-label and dose escalation study aimed at exploring the safety and MTD of HLX22. three dose levels are designed for HLX22 in this study: 3, 10, and 25 mg/kg/3 weeks. The 3 mg/kg/3 weeks will serve as the starting dose. The study will use a 3+3 design to assign doses to the patients, and thereby determine the MTD of HLX22.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	HLX22	Humanized Anti-Human Epidermal Growth Factor Receptor-2 Monoclonal Antibody

Timeline

• Start date: 2019-07-31
• Primary completion: 2021-01-04
• Completion: 2021-12-27
• First posted: 2019-04-16
• Last updated: 2022-05-05

Locations

1 site across 1 country: China