NCT01761240

Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC

A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-066, a Humanized Monoclonal Antibody to Human Tissue Factor, in Patients With Advanced or Metastatic Breast, Pancreatic, Colorectal, or Non-Small Cell Lung Cancer (Adenocarcinoma) Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Morphotek · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	MORAb-066	MORAb-066 infusion.

Timeline

• Start date: 2013-06-19
• Primary completion: 2016-02-09
• Completion: 2016-02-09
• First posted: 2013-01-04
• Last updated: 2024-03-29
• Results posted: 2024-03-29

Locations

2 sites across 1 country: United States