Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
NCT01761240 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2024-03-29
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.
Conditions
- Breast Cancer
- Pancreatic Cancer
- Colorectal Cancer
- Carcinoma, Non-Small-Cell Lung
- Adenocarcinoma
Interventions
- DRUG
-
MORAb-066
MORAb-066 infusion.
Sponsors & Collaborators
-
SCRI Development Innovations, LLC
collaborator OTHER -
Morphotek
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-19
- Primary Completion
- 2016-02-09
- Completion
- 2016-02-09
Countries
- United States
Study Locations
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