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


N/A
18 Years
N/A
Not Enrolling
Both
Mesothelioma, Pancreatic Cancer, Ovarian Cancer, Non-small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MORAb-009-006

NCT ID:

NCT01521325

Start Date:

September 2011

Completion Date:

March 2013

Related Keywords:

  • Mesothelioma
  • Pancreatic Cancer
  • Ovarian Cancer
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Mesothelioma
  • Ovarian Neoplasms
  • Pancreatic Neoplasms

Name

Location

National Cacner InstitueBethesda, Maryland  20892`