Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Zanidatamab is a bispecific antibody that targets HER2, a protein that can promote cancer cell growth. By binding to HER2, the antibody is designed to interfere with cancer cell signaling. This mechanism is being studied in HER2-positive cancers, including breast cancer.
Zanidatamab is being developed by BeOne Medicines Ltd., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol ONC. BeOne Medicines is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
Zanidatamab is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The drug is being studied in clinical trials to assess its safety, tolerability, and potential efficacy in treating certain cancers.
Zanidatamab is being studied in clinical trial NCT04276493, titled 'Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab.' This Phase 1 trial has been completed and enrolled 71 participants with breast cancer, gastric cancer, or gastroesophageal junction cancer.
Yes, Zanidatamab is also known as ZW25. The clinical trial NCT04276493 refers to the drug as 'Zanidatamab (ZW25),' confirming that these names refer to the same investigational bispecific antibody. This alternative name may appear in scientific literature and clinical trial registries.