Clinical Trial · NCT01521325

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 1

Contacts

Raffit Hassan, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01521325

Drug / Compound

amatuximab

Isotope(s):

Target(s):

MSLN

Ligand Class: Antibodies

Chelator: CHX-A''

Eligibility

Inclusion

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
Histologically confirmed mesothelin-expressing cancer

Exclusion

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