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Also known as Margetuximab Margetuximab-IV
Margetuximab Margetuximab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Margetuximab & Chosen Chemotherapy | EXPERIMENTAL | The dosage and administering of margetuximab is 15 mg/kg IV every 21 days. Investigators need to choose one of the 3 chemotherapies based on patient conditions. |
| Name | Type | Description |
|---|---|---|
| Margetuximab Margetuximab-IV | DRUG | Drug: Chosen Chemotherapy (Capecitabine) -Oral Capecitabine tablet Drug: Chosen Chemotherapy (Vinorelbine) Vinorelbine -IV Drug: Chosen Chemotherapy (Gemcitabine) Gemcitabine -IV |
Inclusion Criteria: * Written informed consent obtained prior to performing any protocol-related procedures * Male or female, age ≥ 18 years old at the time of screening. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Subject has histologically confirmed HER2 positive me...
Margetuximab is being studied for HER2 positive metastatic breast cancer, a form of breast cancer that overexpresses the HER2 protein. It is an investigational monoclonal antibody being developed by Zai Lab Limited. The clinical program has focused on patients with HER2 positive metastatic breast cancer in China.
Margetuximab targets ERBB2, also known as HER2, a receptor tyrosine kinase that is overexpressed in certain breast cancers. It is classified as an inhibitor of ERBB2. By binding to this target, the antibody is designed to interfere with HER2-driven signaling in HER2 positive metastatic breast cancer.
Margetuximab is being developed by Zai Lab Limited, which trades under the ticker ZLAB. Zai Lab is the sponsor of the clinical program evaluating the drug in HER2 positive metastatic breast cancer. The company is responsible for advancing this monoclonal antibody through clinical development.
Margetuximab is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved for commercial use. The Phase 1 program has evaluated the drug in patients with HER2 positive metastatic breast cancer.
Margetuximab has been evaluated in the Phase 1 trial NCT04398108, titled A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC. This completed trial enrolled 16 patients in China with HER2 positive metastatic breast cancer. It was an uncontrolled study without randomization or double blinding.
Yes, Margetuximab-IV is an alternative name for Margetuximab. Both names refer to the same monoclonal antibody being developed by Zai Lab Limited for HER2 positive metastatic breast cancer. The intravenous formulation is the subject of the clinical development program.