NCT05360368

HLX07(Anti-EGFR mAb) in Patients With Advanced or Metastatic Solid Tumors

A Phase I Clinical Study To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	HLX07	A Recombinant Humanized Anti-EGFR Monoclonal Antibody, HLX07 will be administered as a single intravenous (IV) infusion on Day 1 in each 3-week cycle

Timeline

• Start date: 2023-03-30
• Primary completion: 2023-12-30
• Completion: 2024-02-28
• First posted: 2022-05-04
• Last updated: 2022-05-05

Locations

1 site across 1 country: China