Brief Title
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
Official Title
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
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, pancreatic, ovarian or non small cell lung cancer.
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, pancreatic, ovarian, and non small cell lung cancer. This is a single-center,
single-dose, open-label, pilot study of amatuximab in approximately 20 subjects with
mesothelin expressing tumors. 111Indium-radiolabeled amatuximab (5 mCi) will be administered.
Serial SPECT imaging (at 3 specific time points up to 196 hours after cold infusion) will be
performed to determine binding to tumor and nontumor tissue. Subjects will be observed
closely for safety and possible development of anti-amatuximab antibodies. Pharmacokinetics
of radiolabeled antibody will be determined with imaging over time.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue
Secondary Outcome
Secondary objectives: determine the safety of a single IV of Indium-CHX-A amatuximab
Condition
Mesothelioma
Intervention
Amatuximab
Study Arms / Comparison Groups
Amatuximab infusion
Description: Subjects will receive one infusion of radiolabeled amatuximab.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
6
Start Date
September 2011
Completion Date
March 2013
Primary Completion Date
March 2013
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Raffit Hassan, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01521325
Organization ID
MORAb-009-006
Responsible Party
Sponsor
Study Sponsor
Morphotek
Study Sponsor
Raffit Hassan, MD, Principal Investigator, National Institutes of Health (NIH)
Verification Date
September 2016