A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
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.
Checked against the public recordLast updated Sep 30, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Basic Science
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Morphotek
- Interventions being studied
- Drug: Amatuximab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- National Cacner InstitueBethesda, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 30, 2016. Always confirm current availability with the study team.