HLX02 clinical trials
Also written HLX02.
A product of Trastuzumab; its studies count on that page too.
How each study uses HLX02 has had a first review. Readers can ask us to read every study one by one.Ask us to read each study
Approvals
The first approval found in each region, with its record
- United States
- 25 Sept 1998 · HERCEPTIN · BLA 103792 (FDA, Drugs@FDA; as Trastuzumab)
- European Union
- 28 Aug 2000 · Herceptin · EMEA/H/C/000278 (EMA; as Trastuzumab)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Development codes
- HLX02
- 3
Studies by the year they started
3 studies that test it; most in 2015 (1)
| Year | Studies |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2021 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 3 · Other 0
Related medicines
As reviewed, each with the page that says it.
- A biosimilar of Trastuzumab
Studies
Open first, then newest update. How each study uses HLX02 has had a first review, but it may not be perfect: check the study record before relying on it for anything important, and report a problem from its row. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 3
- Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast CancerCompletedPhase 3Shanghai Henlius BiotechNCT03084237Written as HLX02Report a problem
- A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male SubjectsCompletedPhase 1Shanghai Henlius BiotechNCT02581748Written as HLX02Report a problem
- A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male SubjectsCompletedPhase 1Shanghai Henlius BiotechNCT04670796Written as HLX02Report a problem
Tested on its own · 1 — no other medicine in its arm
Tested with established drugs · 2 — they are given beside it
- Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast CancerCompletedPhase 3Shanghai Henlius BiotechNCT03084237Written as HLX02Report a problem
- A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male SubjectsCompletedPhase 1Shanghai Henlius BiotechNCT02581748Written as HLX02Report a problem