A Study Of MORAb-009 In Subjects With Pancreatic Cancer, Mesothelioma, Or Certain Types Of Ovarian Or Lung Cancer

Study Overview

A Study of MORAb-009 in Subjects With Pancreatic Cancer, Mesothelioma, or Certain Types of Ovarian or Lung Cancer

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.

Pancreatic Cancer
Mesothelioma
Ovarian Cancer
Non-Small Cell Lung Cancer

DRUG: MORAb-009

MORAb-009-001

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 2006-05-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-07-16
First Submitted that Met QC Criteria 2006-05-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-07-17
First Posted (ESTIMATED) 2006-05-12	Results First Posted N/A	Last Verified 2014-07

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:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cohort 1 MORAb-009 weekly dose of 12.5 mg/m^2	DRUG: MORAb-009 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.
EXPERIMENTAL: Cohort 2 MORAb-009 weekly dose of 25 mg/m^2	DRUG: MORAb-009 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.
EXPERIMENTAL: Cohort 3 MORAb-009 weekly dose of 50 mg/m^2	DRUG: MORAb-009 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.
EXPERIMENTAL: Cohort 4 MORAb-009 weekly dose of 100 mg/m^2	DRUG: MORAb-009 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.
EXPERIMENTAL: Cohort 5 MORAb-009 weekly dose of 200 mg/m^2	DRUG: MORAb-009 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.
EXPERIMENTAL: Cohort 6 MORAb-009 weekly dose of 400 mg/m^2	DRUG: MORAb-009 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.

Primary Outcome Measures	Measure Description	Time Frame
Safety and Tolerability as a measure of Adverse Events/Serious Adverse Events		35 day treatment and observation period, or until disease progession occurs
Safety and Tolerability as a measure of clinical laboratory parameters		35 day treatment and observation period, or until disease progession occurs
Safety and Tolerability as a measure of physical examinations, vital signs, and ECGs		35 day treatment and observation period, or until disease progession occurs

Secondary Outcome Measures	Measure Description	Time Frame
Pharmacokinetics of MORAb-009	Blood samples will be analyzed using ELISA for concentration of MORAb-009.	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])		35 day treatment and observation period
Objective Tumor Response Rate Assessed by Investigator	CT; MRI; RECIST criteria; biomarkers	35 day treatment and observation period

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 or male subjects, ≥ 18 years of age, with a histologically confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma, or mesothelin-positive ovarian or non-small cell lung cancer. As nearly 100% of pancreatic adenocarcinoma and mesotheliomas express mesothelin, immunohistochemical confirmation of mesothelin-positivity is not necessary.
Subject must have disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable by clinical signs/symptoms (e.g., ascites, pleural effusion, or lesions of less than 2 cm) supported by biomarker, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.
Subject must have failed at least one standard chemotherapy regimen. Patients with pancreatic cancer must have received gemcitabine as part of prior therapy and be considered refractory, or in the case of ovarian cancer be considered platinum refractory or resistant.
Life expectancy ≥ 3 months, as estimated by the investigator.
Eastern Cooperative Oncology Group performance status or 0, 1 or 2.
Female subjects of childbearing potential and all male subjects must consent to use a medically acceptable method of contraception throughout the study period and for 28 days after MORAb-009 administration. A barrier method of contraception must be included.
Other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1.
Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:

Known central nervous system (CNS) tumor involvement.
Evidence of other active malignancy requiring treatment.
Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
ECG demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
Active serious systemic disease, including active bacterial or fungal infection.
Active hepatitis or HIV infection.
Treatment within three months with immunomodulatory therapy (e.g. interferons, immunoglobulin therapy, IL-1RA or systemic corticosteroids). Short term systemic corticosteroids or topical or intra-articular steroids are acceptable, subject to the judgment of the investigator.
Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to dosing with MORAb-009.
Breast-feeding, pregnant, or likely to become pregnant during the study.

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Susan C. Weil, M.D., Morphotek

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

Learn

Resources

PatientS

Caregivers

Clinical Trial Record