Amatuximab for High Mesothelin Cancers

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2013
• Main ID: NCT01413451
• Date of registration: 09/08/2011
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Amatuximab for High Mesothelin Cancers
• Scientific title: A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
• Date of first enrolment: July 2011
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01413451
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

• Name: Yvonne D Mallory, R.N.

• Name: Raffit Hassan, M.D.
• Affiliation: National Cancer Institute (NCI)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

- Female or male subjects, greater than or equal to 18 years of age.

- Histologically-confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma,
mesothelin-positive ovarian cancer, or NSCLC. A new biopsy is not required; the
diagnostic biopsy sample will be sufficient. IHC confirmation of
mesothelin-positivity is not necessary for pancreatic adenocarcinoma and mesothelioma
as nearly 100% of pancreatic adenocarcinomas and mesotheliomas express mesothelin.
Mesothelin expression in ovarian cancer and NSCLC will be tested by IHC and any
degree of positivity (1+, 2+, or 3+) will be accepted.

- Subjects are required to have measurable disease that has progressed through prior
therapy and that includes a non-hepatic lesion for imaging that is greater than or
equal to 1.5 cm, as defined by Modified Response Evaluation Criteria in Solid Tumors
(RECIST).

- Eastern Cooperative Oncology Group (ECOG) performance status or 0, 1, or 2.

- Female subjects of childbearing potential and all male subjects are required to
consent to use a medically acceptable method of contraception throughout the study
period and for 30 days after amatuximab administration. A barrier method of
contraception is required.

- Laboratory and clinical results within the 2 weeks prior to Day of Infusion as
follows:

- Absolute neutrophil count (ANC): greater than or equal to 1.5 times 10(9)/L

- Platelet count: greater than or equal to 75 times 10(9)/L

- Hemoglobin: greater than or equal to 9 g/dL

- Serum bilirubin: less than or equal to 1.5 mg/dL

- Aspartate transaminase (AST): less than or equal to 3 x upper limit of normal
(ULN) (less than or equal to 5 ULN acceptable for pancreatic patients with known
liver metastasis only)

- Alanine transaminase (ALT) less than or equal to 3 times upper limit of normal
(ULN) (less than or equal to 5 ULN acceptable for pancreatic patients with known
liver metastasis only)

- Alkaline Phosphatase less than or equal to 5 times ULN

- Serum creatinine less than or equal to 1.5 mg/dL

- Subjects are required to be willing and able to provide written informed consent.

EXCLUSION CRITERIA:

- Subjects are ineligible to participate in this study if any of the following criteria
are met:

- Known allergy or hypersensitivity to monoclonal antibodies;

- Prior treatment with amatuximab;

- Prior treatment with SS1(dsFv)PE38 (SS1P);

- Known brain metastases;

- Known prosthetic devices that would prohibit imaging of lesion of interest due
to radiographic artifact;

- 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. Subjects with chronic
atrial arrhythmia, (i.e., atrial fibrillation or paroxysmal supraventricular
tachycardia), are eligible;

- Active serious systemic disease, including active bacterial or fungal infection
within 2 weeks before study entry;

- Active viral hepatitis or symptomatic human immunodeficiency virus (HIV)
infection;

- Treatment within 3 months with immunomodulatory therapy (e.g., interferons,
immunoglobulin therapy, Interleukin 1 receptor antagonist (IL-1RA) or systemic
corticosteroids). Short-term systemic corticosteroids or topical or
intra-articular steroids are acceptable, at the discretion of the Investigator;

- Chemotherapy, biologic therapy, radiation therapy or immunotherapy within 3
weeks prior to dosing with amatuximab;

- Breast-feeding, pregnant, or likely to become pregnant during the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Carcinoma, Non-Small-Cell Lung

Carcinoma, Pancreatic Ductal

Mesothelioma

Ovarian Neoplasms

Intervention(s)

Drug: Amatuximab (MORab-009)

Primary Outcome(s)

Background ratio of maximum counts

Biodistribution of radiolabelled amatuximab in tumor and nontumor tissues.

Tumor

Secondary Outcome(s)

Antibody uptake vs. IHC mesothelin expression

CTCAE V.4 events

Observation of HACA

PKs

Secondary ID(s)

11-C-0212

110212

Source(s) of Monetary Support

Please refer to primary and secondary sponsors