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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02576548 | A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. | PHASE1 | COMPLETED | 47 | — | — | Sep 23, 2015 | May 23, 2018 | Jun 18, 2019 | 5 | United States |
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,...