drugset / Trial / NCT02069145
Dose Escalation Study of OMP-54F28 in Combination With Sorafenib in Patients With Hepatocellular Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of OMP-54F28 when combined with sorafenib. OMP-54F28 will be administered IV on Day 1 of each 21-day cycle. The planned dose levels of OMP-54F28 are 5 and 10 mg/kg. Depending on safety in this study, additional lower or intermediate dose levels may be evaluated.
Timeline
- Start
- 2014-01
- Primary completion
- 2017-05
- Completion
- 2017-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IPAFRICEPT | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Subject | IPAFRICEPT | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Background | Sorafenib | Small molecule | 400 mg | Oral |