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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521325
• Other study ID #: MORAb-009-006
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2011
• Last updated: September 28, 2016
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2016
• Source: Morphotek
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Amatuximab
Subjects will receive one infusion of radiolabeled amatuximab.

Locations

Country	Name	City	State
United States	National Cacner Institue	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Morphotek

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue	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.	1 year	No
Secondary	Secondary objectives: determine the safety of a single IV of Indium-CHX-A amatuximab	To determine the safety of a single IV of Indium-CHX-A amatuximab by collecting safety data during/ after the infusions as well as obtain any potential drug-related AEs 30 days post infusion	1 year	Yes
Secondary	Pharmacokinetic and serum levels	To determine the PK parameters of the Indium-CHX-A amatuximab with imaging, and serum levels collected over time	1 year	No
Secondary	uptake of Indium-CHX-A amatuximab	To explore the uptake of Indium-CHX-A amatuximab with mesothelin tumor expression as determined by ICH	1 year	No
Secondary	occurrence of HACA	To tabulate the occurrence of HACA which will be measured through serum samples collected over time	1 year	No
Secondary	correlate shed serum mesothelin to imaging	To correlate shed serum mesothelin to imaging obtained after antibody administration.	1 year	No