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Also known as ZW25
Zanidatamab · 1 trial · 3 indications
Defined as the percentage of participants who had a best overall response of complete response or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
| Arm | Type | Description |
|---|---|---|
| Cohort 1- Zanidatamab + Docetaxel | EXPERIMENTAL | Zanidatamab intravenous (IV) infusion followed by docetaxel IV infusion first-line therapy once every three weeks (Q3W) in female participants with metastatic breast cancer |
| Cohort 2- Zanidatamab + Tiselizumab + Chemotherapy | EXPERIMENTAL | Zanidatamab intravenous (IV) infusion followed by tislelizumab IV infusion and CAPOX chemotherapy (oral capecitabine + IV oxaliplatin) first-line therapy once every three weeks (Q3W) in participants with metastatic gastric / GEJ adenocarcinoma |
| Name | Type | Description |
|---|---|---|
| Zanidatamab | BIOLOGICAL | Administered intravenously |
| Docetaxel | DRUG | Administered intravenously |
| Tislelizumab | BIOLOGICAL | Administered intravenously |
| Capecitabine | DRUG | Administered orally |
| Oxaliplatin | DRUG | Administered intravenously |
Key Inclusion Criteria: 1. Disease diagnosis and prior treatment: 1. Cohort 1 (the first-line breast cancer treatment cohort): * Female participants with histologically or cytologically confirmed unresectable, locally advanced, recurrent or metastatic adenocarcinoma of the breast and can...
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Zanidatamab is an investigational monoclonal antibody being studied for the treatment of breast cancer. It is also being evaluated in gastric cancer and gastroesophageal junction cancer. As of the available data, it is in Phase 1 clinical development and has not been approved by regulatory authorities.
Zanidatamab targets ERBB2, also known as HER2, and acts as an inhibitor of this molecular target. It is a monoclonal antibody designed to interfere with ERBB2 signaling, which is relevant in certain cancers. This mechanism is being explored in clinical trials for breast cancer and other ERBB2-expressing tumors.
Zanidatamab is being developed by BeOne Medicines Ltd., a company listed under the ticker ONC. The company is conducting clinical research on this asset as part of its oncology pipeline.
Zanidatamab is in Phase 1 clinical development. It is an investigational drug and has not yet received FDA approval. The available data indicates it is still in early-stage trials, with one completed Phase 1 study.
Zanidatamab has been studied in one clinical trial, NCT04276493, which was a Phase 1 study. This trial evaluated the drug in combination with chemotherapy, with or without tislelizumab, in patients with breast cancer, gastric cancer, and gastroesophageal junction cancer. The trial has been completed.
Zanidatamab is also known as ZW25, as referenced in the clinical trial title. The trial NCT04276493 describes Zanidatamab as an anti-HER2 bispecific antibody, and ZW25 is an alternative name for this drug.