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

NCT ID: NCT01521325

Last Updated: 2016-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-03-31

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.

Conditions

Mesothelioma; Pancreatic Cancer; Ovarian Cancer; Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Amatuximab infusion

Subjects will receive one infusion of radiolabeled amatuximab.

Group Type: EXPERIMENTAL

Amatuximab

Intervention Type: DRUG

Subjects will receive one infusion of radiolabeled amatuximab.

Interventions

Amatuximab

Subjects will receive one infusion of radiolabeled amatuximab.

Intervention Type: DRUG

Other Intervention Names

MORAb-009; MORAB-009-006

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Morphotek

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raffit Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

National Institutes of Health (NIH)

Locations

National Cacner Institue

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

MORAb-009-006

Identifier Type: -

Identifier Source: org_study_id