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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01521325
First received: January 7, 2011
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Mesothelioma
Pancreatic Cancer
Ovarian Cancer
Non-small Cell Lung Cancer
Drug: Amatuximab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Secondary objectives: determine the safety of a single IV of Indium-CHX-A amatuximab [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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

  • Pharmacokinetic and serum levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To determine the PK parameters of the Indium-CHX-A amatuximab with imaging, and serum levels collected over time

  • uptake of Indium-CHX-A amatuximab [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To explore the uptake of Indium-CHX-A amatuximab with mesothelin tumor expression as determined by ICH

  • occurrence of HACA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To tabulate the occurrence of HACA which will be measured through serum samples collected over time

  • correlate shed serum mesothelin to imaging [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To correlate shed serum mesothelin to imaging obtained after antibody administration.


Enrollment: 6
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521325

Locations
United States, Maryland
National Cacner Institue
Bethesda, Maryland, United States, 20892`
Sponsors and Collaborators
Morphotek
Investigators
Principal Investigator: Raffit Hassan, MD National Institutes of Health (NIH)
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01521325     History of Changes
Other Study ID Numbers: MORAb-009-006
Study First Received: January 7, 2011
Last Updated: November 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Mesothelioma
Neoplasms, Mesothelial
Ovarian Neoplasms
Pancreatic Neoplasms
Adenoma
Adnexal Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Pancreatic Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014