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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02248805 | Phase 1 Study of MGD007 in Relapsed/Refractory Metastatic Colorectal Carcinoma | PHASE1 | COMPLETED | 95 | — | — | Oct 1, 2014 | Jul 2, 2018 | Feb 8, 2022 | 8 | United States |
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit. The MTD will be defined separately for both the weekly and every three week schedules of MGD007 administration, and will be determined as the highest dose level at which the incidence of DLT is \< 33% during the first cycle of MGD007 treatment.
| Arm | Type | Description |
|---|---|---|
| Does Escalation Arm A | EXPERIMENTAL | MGD007 treatment once weekly |
| Dose Escalation Arm B | EXPERIMENTAL | MGD007 treatment once every 3 weeks |
| Dose Expansion Arm C | EXPERIMENTAL | MGD007 once every 3 weeks for K-ras wild-type and mutant metastatic CRC |
| Dose Expansion Arms | EXPERIMENTAL | MGD007 2, 3, 6, or 12 doses/cycle |
| Name | Type | Description |
|---|---|---|
| MGD007 | DRUG | MGD007 is a gpA33 x CD3 bi-specific antibody-based molecular construct referred to as a DART molecule. MGD007 will be administered as a single agent. |
Inclusion Criteria: * For the dose escalation cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 2 prior standard treatment regimens or standard treatment was declined. * For the dose expansion cohorts, histologically-proven metastatic colorectal adenocarcinom...