drugset / Trial / NCT07601620
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .
Timeline
- Start
- 2026-07-03
- Primary completion
- 2027-04-23
- Completion
- 2027-07-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | EU-Phesgo | Monoclonal antibody | — | Subcutaneous |
| Subject | HLX319 | Monoclonal antibody | — | Subcutaneous |