Status:
COMPLETED
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
Lead Sponsor:
Morphotek
Conditions:
Mesothelioma
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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, p...
Detailed Description
The primary objective is to determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissues in subjects with mesothelin over-expressing cancers including mesothelioma, pancreati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01521325
Start Date
September 1 2011
End Date
March 1 2013
Last Update
September 30 2016
Active Locations (1)
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1
National Cacner Institue
Bethesda, Maryland, United States, 20892'