Ontuxizumab (MORAb-004)

Ontuxizumab (MORAb-004) clinical studies are designed to investigate ontuxizumab's safety and efficacy in patients with a variety of cancers that express the antibody's target, endosialin [also known as Tumor Endothelial Marker-1 (TEM-1)]. Ontuxizumab is currently in clinical development for melanoma, sarcoma and colorectal cancer.

More information on active clinical trials can be found below and by visiting ClinicalTrials.gov.

Current Studies

MORAb-004-J081-103 Phase 1 Study (Active; not recruiting)

MORAb-004-J081-103 is a Phase 1 study to evaluate the safety of MORAb-004 in Japanese patients with solid tumors.

For more information and details on this trial, please visit ClinicalTrials.gov. (Indentifier: NCT01773434)


MORAb-004-201-MEL Phase 2 Study (Active; not recruiting)

MORAb-004-201-MEL is a multicenter Phase 2 study in advanced malignant melanoma. The study tests two doses of ontuxizumab as a single agent in patients who have failed other therapies. The goal of the study is to investigate the effect of ontuxizumab on progression-free survival compared to historical control and to identify biomarkers that may serve as an indicator of response to therapy.

For more information visit ClinicalTrials.gov. (Identifier: NCT01335009)


MORAb-004-203-STS Phase 2 Study (Active; not recruiting)

MORAb-004-203-STS (SOURCE: Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation) is a clinical study that evaluates the safety and efficacy of ontuxizumab when combined with gemcitabine and docetaxel in the treatment of metastatic soft tissue sarcoma. The trial is a randomized, double-blind, placebo-controlled study with a primary endpoint of progression-free survival. Secondary objectives include assessment of an overall survival benefit, identification of biomarkers to predict efficacy, and safety of MORAb-004 in combination with gemcitabine and docetaxel. The trial will explore the clinical effects of ontuxizumab in the four major subtypes of sarcoma.

For more information and details on this study, please visit ClinicalTrials.gov. (Identifier: NCT01574716)

For more information about MORAb-004, please click here.


The information contained herein is investigational and is not intended to make claims of safety or efficacy prior to approval by the FDA or other regulatory authorities. There is no guarantee that the agents described or their uses will be approved by the FDA or other regulatory authorities.