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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02482441 | A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10 | PHASE1 | COMPLETED | 50 | — | — | Jul 16, 2015 | Mar 28, 2018 | Aug 11, 2020 | 7 | United States |
Subject will be assessed for DLTs during the evaluation window (28 days). Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined.
| Arm | Type | Description |
|---|---|---|
| OMP-131R10 intravenous (in the vein) infusions | EXPERIMENTAL | OMP-131R10 will be administered IV on the first day of each 14-day cycle. |
| FOLFIRI (5-FU, irinotecan, leucovorin). | EXPERIMENTAL | dosing continues up to the 20 mg/kg dose level |
| Name | Type | Description |
|---|---|---|
| OMP-131R10 | DRUG | There are 5 planned dose cohorts of OMP-131R10. Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity. |
| FOLFIRI | DRUG | Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen. |
Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for the study: 1. Phase 1a portion: Histologically confirmed advanced relapsed or refractory solid tumors that have exhausted standard of care therapy or either refuse or are not considered to be candidates for any...