drugset / Trial / NCT03494231

A Study of HLX06, a Humanized Monoclonal Antibody Targeting Human Vascular Endothelial Growth Factor Receptor-2 in Patients With Advanced Solid Tumors

NCT03494231 ↗

Phase 1 Terminated 5 enrolled Henlix, Inc
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of fully human anti-VEGFR2 monoclonal antibody, HLX06, in patients with advanced or metastatic tumors refractory to standard therapy. This study will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of HLX06 and explore the potential prognostic and predictive biomarkers.

Timeline

Start
2018-03-22
Primary completion
2019-05-17
Completion
2019-05-30

Outcome

Outcome not reported

Stopped: “Lack of efficacy”

Drugs

EvaluationDrugModalityDoseRoute
Subject VULINACIMAB Monoclonal antibody 500 mg Intravenous
Subject VULINACIMAB Monoclonal antibody 750 mg Intravenous
Subject VULINACIMAB Monoclonal antibody 900 mg Intravenous
Subject VULINACIMAB Monoclonal antibody 1200 mg Intravenous
Subject VULINACIMAB Monoclonal antibody 1500 mg Intravenous

Indications