HLX02

DRUG3 trials

Sponsors

Shanghai Henlius Biotech

Conditions

Breast CancerHealthy

Phase 1

A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects

CompletedNCT02581748

Shanghai Henlius BiotechHealthy

Start: 2015-09-16End: 2017-01-25Updated: 2022-06-03

A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects

CompletedNCT04670796

Shanghai Henlius BiotechHealthy

Start: 2021-03-02End: 2021-06-04Updated: 2022-06-03

Phase 3

Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer

CompletedNCT03084237

Shanghai Henlius BiotechBreast Cancer

Start: 2016-11-30End: 2021-09-28Updated: 2024-05-17

Related Papers

Updated efficacy and safety of HLX02 versus reference trastuzumab in metastatic HER2-positive breast cancer: A randomized phase III equivalence trial

The Breast2025-02-041 citations

Efficacy, Safety, and Immunogenicity of HLX02 Compared with Reference Trastuzumab in Patients with Recurrent or Metastatic HER2-Positive Breast Cancer: A Randomized Phase III Equivalence Trial.

2021-04-0726 citations

A Phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX02 to reference CN- and EU-sourced trastuzumab in healthy subjects.

2020-11-0914 citations