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

Morphotek

Status and phase

Completed

Phase 1

Conditions

Non-small Cell Lung Cancer

Mesothelioma

Ovarian Cancer

Pancreatic Cancer

Treatments

Drug: Amatuximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01521325

MORAb-009-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No 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