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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 30, 2016 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.