A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers

Conditions
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Mesothelioma, Pancreatic Cancer, Ovarian Cancer, Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Amatuximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amatuximab infusion<br>Subjects will receive one infusion of radiolabeled amatuximab. | Drug: Amatuximab<br>* Subjects will receive one infusion of radiolabeled amatuximab.<br>* Other names: MORAB-009-006;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue | To determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissue in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or nonsmall cell lung cancer by performing SPECT imaging to determine binding to tumor and non-tumor tissue. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary objectives: determine the safety of a single IV of Indium-CHX-A amatuximab | To determine the safety of a single IV of Indium-CHX-A amatuximab by collecting safety data during/ after the infusions as well as obtain any potential drug-related AEs 30 days post infusion | 1 year | 
| Pharmacokinetic and serum levels | To determine the PK parameters of the Indium-CHX-A amatuximab with imaging, and serum levels collected over time | 1 year | 
| uptake of Indium-CHX-A amatuximab | To explore the uptake of Indium-CHX-A amatuximab with mesothelin tumor expression as determined by ICH | 1 year | 
| occurrence of HACA | To tabulate the occurrence of HACA which will be measured through serum samples collected over time | 1 year | 
| correlate shed serum mesothelin to imaging | To correlate shed serum mesothelin to imaging obtained after antibody administration. | 1 year |