Dose Escalation Study MORAb-066 Targeting TF-expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
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 MTD when MORAb-066 is administered IV once weekly on a 28-day cycle.
Non-small-cell Lung Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of the Safety, Tolerability, and PK of MORAb-066, a Humanized Monoclonal Antibody to Human TF, in Patients With Advanced or Metastatic Breast, Pancreatic, Colorectal, or NSCLC (Adenocarcinoma) Malignancies|
- Maximum Tolerated Dose [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
• To evaluate the safety and tolerability of weekly intravenous (IV) infusions of MORAb-066.
- To identify the dose-limiting toxicities (DLT) and to determine the maximum tolerated dose (MTD) of MORAb-066.
- To characterize the pharmacokinetic (PK) properties of MORAb-066.
- To identify, on the basis of safety, PK, and pharmacodynamics (PDx) data, a recommended Phase II dose and schedule for MORAb-066.
- To make a preliminary assessment of the antitumor activity of MORAb-066.
- To detect any antibody response (i.e., human antihuman antibodies [HAHA]) to multiple IV infusions to MORAb-066.
- To evaluate the presence of tissue factor (TF) substrates such as protease activated receptor 2 when applicable.
- To evaluate the archived tumor tissue for TF overexpression by immunohistochemistry.
- To evaluate whether there are potential biomarkers that correlate responses to MORAb-066.