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Also known as MCLA-128
Zenocutuzumab · 1 trial · 1 indication
Clinical benefit rate (CBR) at 24 weeks per investigator assessment. CBR is the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR), or Stable Disease (SD) lasting 24 weeks.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 doublet | EXPERIMENTAL | zenocutuzumab + trastuzumab |
| Cohort 1 triplet | EXPERIMENTAL | zenocutuzumab + trastuzumab + vinorelbine |
| Cohort 2 | EXPERIMENTAL | zenocutuzumab + endocrine therapy |
| Name | Type | Description |
|---|---|---|
| Zenocutuzumab | DRUG | full length immunoglobulin gamma-1 (IgG1) bispecific antibody targeting Human Epidermal Growth Factor Receptor (HER)2 and HER3 |
| Trastuzumab | DRUG | humanised IgG1 monoclonal antibody |
| Vinorelbine | DRUG | antineoplastic drug of vinca alkaloid family |
| Endocrine therapy | DRUG | same endocrine therapy is administered as the last line of endocrine therapy |
Inclusion Criteria 1. Signed informed consent before initiation of any study procedures. 2. Women with histologically or cytologically confirmed breast cancer with evidence of metastatic or locally advanced disease not amenable to any local therapy with curative intent: 2.1 Cohort 1 (zenocutuzu...
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Zenocutuzumab is being studied in metastatic breast cancer. It was evaluated in a Phase 2 trial in HER2-positive breast cancer combined with trastuzumab and chemotherapy, and in ER-positive, low HER2 breast cancer combined with endocrine therapy. It is an investigational therapy and has not been approved for commercial use.
Zenocutuzumab targets ERBB2 and ERBB3, also known as HER2 and HER3. It is a monoclonal antibody that acts as an inhibitor of these receptors. By binding both targets, it is designed to interfere with HER2/HER3-driven signaling in tumors that depend on this pathway.
Zenocutuzumab is being developed by Merus N.V., a clinical-stage oncology company. Merus trades on the Nasdaq under the ticker symbol MRUS. The company is the sponsor of the clinical program evaluating zenocutuzumab in breast cancer and other solid tumors.
Zenocutuzumab is in Phase 2 clinical development. The Phase 2 trial in metastatic breast cancer has been completed. The drug remains investigational and has not received FDA approval. It is a monoclonal antibody studied in biomarker-selected patient populations.
Zenocutuzumab has been studied in the Phase 2 trial NCT03321981, titled MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer. The trial enrolled 105 female patients aged 18 years and older across the United States and several European countries, and it is now completed.
Yes, zenocutuzumab is also known as MCLA-128. MCLA-128 is the earlier code name used for the same monoclonal antibody in clinical trials. Both names refer to the ERBB2 and ERBB3 inhibitor developed by Merus N.V. for metastatic breast cancer and other solid tumors.