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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Ovarian Cancer; Mesothelioma; Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Amatuximab

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892'
      • National Cacner Institue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

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.; Other Names: MORAb-009; MORAB-009-006

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Morphotek
• Investigators: Principal Investigator: Raffit Hassan, MD, National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: January 7, 2011
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (ESTIMATE): January 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 28, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Neoplasms, Mesothelial; Mesothelioma; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: MORAb-009-006