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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01391143 | Safety Study of MGA271 in Refractory Cancer | PHASE1 | COMPLETED | 179 | — | — | Jul 1, 2011 | Apr 18, 2019 | Feb 8, 2022 | 12 | United States |
Adverse events, serious adverse events, ECG monitoring, adrenal function monitoring, monitoring for development of anti-drug antibodies
| Arm | Type | Description |
|---|---|---|
| MGA271 | EXPERIMENTAL | Fc-optimized, humanized monoclonal antibody |
| Name | Type | Description |
|---|---|---|
| MGA271 | BIOLOGICAL | Up to 9 dose escalation cohorts will be enrolled to determine the maximum tolerated dose of MGA271. Patients with evidence of clinical benefit will be allowed to continue therapy at the same dose once per week for 3 weeks out of every 4-week cycle until documented progression. Patients treated in the Expansion Segment at the maximum administered dose will receive weekly, uninterrupted infusions of MGA271 in 8 week cycles for up to 12 cycles. |
Inclusion Criteria: * Histologically or cytologically confirmed carcinoma (prostate cancer, renal cell carcinoma, head and neck cancer, triple-negative breast cancer, bladder cancer, non-small cell lung cancer) or melanoma that overexpresses B7-H3. * Progressive disease during or after last treatme...