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

Primary Purpose

Mesothelioma, Pancreatic Cancer, Ovarian Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Amatuximab
Sponsored by
Morphotek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cacner Institue

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amatuximab infusion

Arm Description

Subjects will receive one infusion of radiolabeled amatuximab.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Pharmacokinetic and serum levels
To determine the PK parameters of the Indium-CHX-A amatuximab with imaging, and serum levels collected over time
uptake of Indium-CHX-A amatuximab
To explore the uptake of Indium-CHX-A amatuximab with mesothelin tumor expression as determined by ICH
occurrence of HACA
To tabulate the occurrence of HACA which will be measured through serum samples collected over time
correlate shed serum mesothelin to imaging
To correlate shed serum mesothelin to imaging obtained after antibody administration.

Full Information

First Posted
January 7, 2011
Last Updated
September 28, 2016
Sponsor
Morphotek
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1. Study Identification

Unique Protocol Identification Number
NCT01521325
Brief Title
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
Official Title
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Morphotek

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma, Pancreatic Cancer, Ovarian Cancer, Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amatuximab infusion
Arm Type
Experimental
Arm Description
Subjects will receive one infusion of radiolabeled amatuximab.
Intervention Type
Drug
Intervention Name(s)
Amatuximab
Other Intervention Name(s)
MORAb-009, MORAB-009-006
Intervention Description
Subjects will receive one infusion of radiolabeled amatuximab.
Primary Outcome Measure Information:
Title
Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Secondary objectives: determine the safety of a single IV of Indium-CHX-A amatuximab
Description
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
Time Frame
1 year
Title
Pharmacokinetic and serum levels
Description
To determine the PK parameters of the Indium-CHX-A amatuximab with imaging, and serum levels collected over time
Time Frame
1 year
Title
uptake of Indium-CHX-A amatuximab
Description
To explore the uptake of Indium-CHX-A amatuximab with mesothelin tumor expression as determined by ICH
Time Frame
1 year
Title
occurrence of HACA
Description
To tabulate the occurrence of HACA which will be measured through serum samples collected over time
Time Frame
1 year
Title
correlate shed serum mesothelin to imaging
Description
To correlate shed serum mesothelin to imaging obtained after antibody administration.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raffit Hassan, MD
Organizational Affiliation
National Institutes of Health (NIH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cacner Institue
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892'
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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