An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers

Phase 1 Completed 19 enrolled Henlix, Inc

NaSingle-groupOpen-labelTreatment

Summary

This study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of humanized anti-EGFR monoclonal antibody, HLX07, in patients with epithelial cancer who have failed standard therapy and deemed unamenable by conventional therapy. This study will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of HLX07 and explore the potential prognostic and predictive biomarkers.

Timeline

Start: 2016-09
Primary completion: 2019-06-28
Completion: 2019-06-28

Publications

Hou MM, Ho CL, Lin HY, Zhu Y, Zhang X. Phase I first-in-human study of HLX07, a novel and improved recombinant anti-EGFR humanized monoclonal antibody, in patients with advanced solid cancers. Invest New Drugs. 2021 Oct;39(5):1315-1323. doi: 10.1007/s10637-021-01099-1. Epub 2021 Mar 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PIMURUTAMAB	Monoclonal antibody	50 mg	Intravenous
Subject	PIMURUTAMAB	Monoclonal antibody	100 mg	Intravenous
Subject	PIMURUTAMAB	Monoclonal antibody	200 mg	Intravenous
Subject	PIMURUTAMAB	Monoclonal antibody	400 mg	Intravenous
Subject	PIMURUTAMAB	Monoclonal antibody	600 mg	Intravenous
Subject	PIMURUTAMAB	Monoclonal antibody	800 mg	Intravenous
Background	Acetaminophen	Small molecule	500 mg	Oral
Background	Dexamethasone	Small molecule	10 mg	Intravenous
Background	Diphenhydramine	Unknown	30 mg	Intravenous
Background	Ondansetron	Other / unclassified	—	—

An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers

Summary

Timeline

Publications

Drugs

Indications