A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers

Completed · Phase 1

Conditions studied: Mesothelioma, Pancreatic Cancer, Ovarian Cancer, Non-small Cell Lung Cancer

In brief

This research is being conducted to determine the biodistribution of radiolabeled amatuximab in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or non small cell lung cancer.

Key facts

Study ID

NCT01521325

Run by

Morphotek

People needed

6

Starts

2011-09-01

Expected to finish

2013-03-01

Last updated by the study team

2016-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female and Male subjects > or = 18 years of age
• Histologically confirmed mesothelin-expressing cancer
• Measurable disease that has progressed through prior therapy and that includes a non-hepatic lesion for imaging that is > or = 1.5cm, as defined by RECIST v1.1 and disease location, at discretion of the physician, or evaluable by clinical symptoms supported by biomarker, radiological or pathological studies conducted within 4 weeks prior to study entry

You may not qualify if…

• Known allergy or hypersensitivity to monoclonal antibodies
• Known to develop HACA
• Prior treatment with amatuximab
• Prior treatment with SS1 (dsFv)PE38 (ss1P)
• Prior treatment with another test article within previous 30 days
• Known brain metastasis
• Known prosthetic devices that would prohibit imaging ow lesion of interest due to radiographic artifact
• Chemotherapy, biological therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab

Where it is running

• National Cacner Institue — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.