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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morphotek
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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