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

Study Overview

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.

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.

Mesothelioma
Pancreatic Cancer
Ovarian Cancer
Non-small Cell Lung Cancer

DRUG: Amatuximab

MORAb-009-006

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-01-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-09-28
First Submitted that Met QC Criteria 2012-01-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-09-30
First Posted (ESTIMATED) 2012-01-30	Results First Posted N/A	Last Verified 2016-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Basic Science

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Amatuximab infusion Subjects will receive one infusion of radiolabeled amatuximab.	DRUG: Amatuximab Subjects will receive one infusion of radiolabeled amatuximab.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Amatuximab infusion

Subjects will receive one infusion of radiolabeled amatuximab.

DRUG: Amatuximab

Subjects will receive one infusion of radiolabeled amatuximab.

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Raffit Hassan, MD, National Institutes of Health (NIH)

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record