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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 an investigational drug being studied for the treatment of HER2 positive metastatic breast cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in Chinese patients with this condition.
Margetuximab is being developed by Zai Lab Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ZLAB. The company is conducting clinical trials to evaluate the drug's pharmacokinetics in patients with HER2 positive metastatic breast cancer.
Margetuximab is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied for its pharmacokinetic profile in patients with HER2 positive metastatic breast cancer.
Margetuximab has one completed clinical trial registered under NCT04398108, titled "A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC." This Phase 1 study enrolled 16 participants in China and was not randomized or blinded.
Margetuximab is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for HER2 positive metastatic breast cancer. The drug has not completed the clinical trials necessary to establish safety and efficacy for regulatory approval.