Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03321981 | MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer. | PHASE2 | COMPLETED | 105 | — | — | Jan 15, 2018 | Jul 26, 2023 | Mar 7, 2024 | 25 | United States, Belgium +5 |
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...