Clinical trial NCT01521325: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mesothelioma
Pancreatic Cancer
Ovarian Cancer
Non-small Cell Lung Cancer
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue
timeFrame: 1 year
Secondary outcomes:
measure: Secondary objectives: determine the safety of a single IV of Indium-CHX-A amatuximab
timeFrame: 1 year
measure: Pharmacokinetic and serum levels
timeFrame: 1 year
measure: uptake of Indium-CHX-A amatuximab
timeFrame: 1 year
measure: occurrence of HACA
timeFrame: 1 year
measure: correlate shed serum mesothelin to imaging
timeFrame: 1 year
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cacner Institue
state: Maryland
Study officials:
affiliation: National Institutes of Health (NIH)
name: Raffit Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: