Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI4276 · 1 trial · 1 indication
The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
| Arm | Type | Description |
|---|---|---|
| MEDI4276 0.05 mg/kg | EXPERIMENTAL | Participants received IV dose of 0.05 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. |
| MEDI4276 0.1 mg/kg | EXPERIMENTAL | Participants received IV dose of 0.1 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. |
| MEDI4276 0.2 mg/kg | EXPERIMENTAL | Participants received IV dose of 0.2 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. |
| MEDI4276 0.3 mg/kg | EXPERIMENTAL | Participants received IV dose of 0.3 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. |
| MEDI4276 0.4 mg/kg | EXPERIMENTAL | Participants received IV dose of 0.4 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. |
| MEDI4276 0.5 mg/kg | EXPERIMENTAL | Participants received IV dose of 0.5 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. |
| MEDI4276 0.6 mg/kg | EXPERIMENTAL | Participants received IV dose of 0.6 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. |
| MEDI4276 0.75 mg/kg | EXPERIMENTAL | Participants received IV dose of 0.75 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. |
| MEDI4276 0.9 mg/kg | EXPERIMENTAL | Participants received IV dose of 0.9 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. |
| Name | Type | Description |
|---|---|---|
| MEDI4276 | BIOLOGICAL | MEDI4276 is an investigational product |
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically or cytologically documented unresectable, locally advanced or metastatic breast cancer or gastric cancer refractory to standard therapy. 1. For subjects with breast cancer: * Prior treatment with trastuzumab, pertuzumab, and T-DM1,...
MEDI4276 was studied for the treatment of HER2-expressing breast cancer and HER2-expressing gastric or stomach cancer. It was evaluated in adults with select HER2-expressing advanced solid tumors. The program was investigated as an oncology therapeutic and is not an approved treatment for any indication.
MEDI4276 was developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company sponsored the clinical program evaluating the antibody in HER2-expressing advanced solid tumors.
MEDI4276 is an investigational agent that reached Phase 1 clinical development. Its single registered trial was a Phase 1/2 study, and that trial is now completed. The drug has not been approved by the FDA for any indication.
MEDI4276 was evaluated in one registered clinical trial, NCT02576548, titled a Phase 1/2 study of MEDI4276 in adult subjects with select HER2-expressing advanced solid tumors. The trial enrolled 47 participants across sites in the United States and is listed as completed.
MEDI4276 is a monoclonal antibody directed at HER2, a receptor that is overexpressed in certain breast and gastric cancers. The Phase 1/2 trial, NCT02576548, selected patients based on HER2 expression, enrolling adults with HER2-expressing advanced solid tumors.
The MEDI4276 Phase 1/2 trial, NCT02576548, was not randomized and was not double blinded. It used a controlled design and enrolled 47 adults aged 18 years and older with HER2-expressing advanced solid tumors. Healthy volunteers were not included in the study.