The purpose of this study is to establish the safest doses of an investigational drug called MORAb-009 in subjects with pancreatic cancer, mesothelioma, or certain types of ovarian or lung cancer. MORAb-009 is a monoclonal antibody that is directed to an antigen on the surface of these cancers.
MORAb-009 is a high-affinity monoclonal antibody raised against human mesothelin, a membrane glycoprotein thought to be involved in cell adhesion and tightly associated with a range of cancers. It has been shown that mesothelin is over-expressed in pancreatic cancers, mesotheliomas, and ovarian or mesothelin-expressing ovarian or non-small cell lung cancers, while showing little expression in normal tissues. Preclinical experiments indicate that MORAb-009 is a potentially useful anti-cancer agent. This clinical trial is being performed to determine the safety of MORAb-009 in subjects with mesothelin-expressing tumors, as well as to establish serum pharmacokinetics of the antibody, and to assess tumor antigens that may serve as predictors of a response to MORAb-009.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Each dose of investigational product will be given as a continuous infusion ranging from 12.5 mg/m\^2 up to 400 mg/m\^2.
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
National Cancer Institute
Bethesda, Maryland, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Safety and Tolerability as a measure of Adverse Events/Serious Adverse Events
Time frame: 35 day treatment and observation period, or until disease progession occurs
Safety and Tolerability as a measure of clinical laboratory parameters
Time frame: 35 day treatment and observation period, or until disease progession occurs
Safety and Tolerability as a measure of physical examinations, vital signs, and ECGs
Time frame: 35 day treatment and observation period, or until disease progession occurs
Pharmacokinetics of MORAb-009
Blood samples will be analyzed using ELISA for concentration of MORAb-009.
Time frame: Pre-dose, mid-infusion, end of infusion, 30 min, 60 min, 2 hours, and 4 hours post dose
Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA])
Time frame: 35 day treatment and observation period
Objective Tumor Response Rate Assessed by Investigator
CT; MRI; RECIST criteria; biomarkers
Time frame: 35 day treatment and observation period
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