Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational drug being studied for the treatment of metastatic breast cancer. It is being evaluated in combination with other therapies, including trastuzumab and chemotherapy for HER2-positive disease, and with endocrine therapy for estrogen receptor-positive, low HER2 breast cancer.
Zenocutuzumab is a bispecific antibody that targets HER2 and HER3 receptors. By binding to these receptors, it is designed to block signaling pathways that can drive tumor growth in certain breast cancers.
Zenocutuzumab is being developed by Merus N.V., a clinical-stage oncology company. Merus is publicly traded on the Nasdaq under the ticker symbol MRUS.
Zenocutuzumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. It has received Breakthrough Therapy designation from the FDA for its potential use in certain cancers.
Zenocutuzumab has been studied in a completed Phase 2 clinical trial with the identifier NCT03321981. This trial enrolled 105 female participants aged 18 years and older with metastatic breast cancer across multiple countries, including the United States, Belgium, France, the Netherlands, Portugal, Spain, and the United Kingdom.
Yes, Zenocutuzumab is also known as MCLA-128. The clinical trial NCT03321981, which evaluated Zenocutuzumab in metastatic breast cancer, used the name MCLA-128 in its title.