Trials / Unknown
UnknownNCT04924699
A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- Shanghai Miracogen Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of Phase II is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive, unresectable locally advanced or metastatic breast cancer. The primary objective of Phase III is to evaluate the efficacy and safety of MRG002 versus Trastuzumab Emtansine (T-DM1) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer who have been previously treated with trastuzumab (or a biosimilar) and an anti-HER2 tyrosine kinase inhibitor (anti-HER2-TKI) and have progressed on or after the most recent therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MRG002 | Administrated intravenously |
| DRUG | Trastuzumab Emtansine for Injection | Administrated intravenously |
Timeline
- Start date
- 2021-06-30
- Primary completion
- 2023-09-01
- Completion
- 2023-10-01
- First posted
- 2021-06-14
- Last updated
- 2023-03-17
Locations
19 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04924699. Inclusion in this directory is not an endorsement.