drugset / Trial / NCT01761240
Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a Phase I, first in human, dose-escalation study of MORAb-066, an investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets TF-expressing malignancies that include breast, pancreatic, colorectal, and non-small-cell lung cancer (NSCLC) (adenocarcinoma). This open-label study will assess the safety, tolerability, and pharmacokinetics of MORAb-066 administered weekly. This study will identify the maximum tolerated dose (MTD) when MORAb-066 is administered IV once weekly on a 28-day cycle.
Timeline
- Start
- 2013-06-19
- Primary completion
- 2016-02-09
- Completion
- 2016-02-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MORAb-066 | Monoclonal antibody | 0.1 mg/kg | Intravenous |
| Subject | MORAb-066 | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | MORAb-066 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | MORAb-066 | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | MORAb-066 | Monoclonal antibody | 3 mg/kg | Intravenous |