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 is an investigational monoclonal antibody being studied for the treatment of HER2 expressing breast or gastric/stomach cancers. It is designed to target tumors that express the HER2 protein. As of the latest data, it is in Phase 1 clinical development and has not been approved by regulatory authorities.
MEDI4276 targets HER2, a protein that is overexpressed in certain types of breast and gastric cancers. By binding to HER2, it aims to interfere with cancer cell growth and survival. This mechanism is being evaluated in clinical trials for its potential efficacy in HER2-positive tumors.
MEDI4276 is being developed by AstraZeneca PLC, a multinational pharmaceutical company. AstraZeneca is conducting clinical research to evaluate the safety and efficacy of MEDI4276 in patients with HER2-expressing cancers. The company's stock is traded under the ticker symbol AZN.
MEDI4276 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval for commercial use. The Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of MEDI4276 in patients with advanced solid tumors.
MEDI4276 has been studied in a Phase 1/2 clinical trial with the identifier NCT02576548. This trial, titled 'A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors,' enrolled 47 participants with HER2-expressing breast or gastric cancers. The trial has been completed.
MEDI4276 is a distinct investigational monoclonal antibody developed by AstraZeneca. It is not known to be the same as any other approved or investigational drug. Its unique mechanism targets HER2, and it is being evaluated specifically for HER2-expressing breast and gastric cancers.